Evaluation of effectiveness of advanced platelet rich fibrin (A-PRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study

Sneha Dare; Pavan Bajaj

doi:10.12688/f1000research.133342.1

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Study Protocol

Evaluation of effectiveness of advanced platelet rich fibrin (A-PRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study

[version 1; peer review: 2 not approved]

Sneha Dare ¹, Pavan Bajaj¹

PUBLISHED 25 Apr 2023

Author details Author details

¹ Department of Periodontics and Implantology, Datta Meghe Institute of Higher Education & Research, Sawangi (Meghe), Wardha, Maharashtra, 442001, India

Sneha Dare
Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Pavan Bajaj
Roles: Project Administration, Supervision

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Dental implant placement has evolved over time with the introduction of numerous novel protocols. Following tooth extraction throughout the healing phase, alveolar ridge resorption is a potential issue that can be mitigated by the utilisation of a variety of techniques, one of which is the placement of immediate implants. The immediate implant treatment protocol offers numerous benefits, such as minimal surgical procedures, which thereby reduce overall treatment time, preserve bone height, and produce better aesthetic results, particularly in the anterior region.
Such protocols have made implant insertion so much easier that results can now be anticipated more precisely. The distance between the lateral surface of an implant and surrounding alveolus is known as the jumping gap distance (JGD). JGD of >1.5 mm affects spontaneous bone healing. Research incorporating biomaterials such as membranes produced from blood and bone grafts has significantly contributed to the success of this therapy.
Methods: This research will be carried out over the course of a year. Twelve implants will be placed in systemically healthy individuals with one tooth/teeth in the maxilla and/or mandible indicated for extraction. Using a two-stage protocol, implant placement will be done simultaneously after extraction along with augmentation with A-PRF and DFDBA. The second stage surgery will be conducted three months after implant placement. Within 3-6 weeks, abutments will be connected and the final prosthesis will be placed.
Expected results: Crestal bone changes and implant stability after using of A-PRF and DFDBA will serve as indicators to determine the implant's success after 6 months.
Conclusion: The augmentation procedures have shown to be successful in obtaining bone fill and in resolving bone defects that are present in proximity with implants. An immediate implant placement along with bone augmentation may decrease resorption of horizontal bone.
Trial registration: REF/2023/03/064371.

Keywords

Immediate implant, extraction socket, jumping gap distance, A-PRF, DFDBA

Corresponding author: Sneha Dare

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Dare S and Bajaj P. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Dare S and Bajaj P. Evaluation of effectiveness of advanced platelet rich fibrin (A-PRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study [version 1; peer review: 2 not approved]. F1000Research 2023, 12:440 (https://doi.org/10.12688/f1000research.133342.1) First published: 25 Apr 2023, 12:440 (https://doi.org/10.12688/f1000research.133342.1) Latest published: 25 Apr 2023, 12:440 (https://doi.org/10.12688/f1000research.133342.1)

Introduction

Dental implant therapy has advanced over time, resulting in predictable, effective, and successful treatment outcomes. During an immediate implant placement procedure, an implant will be placed straight away into an extraction socket after the tooth extraction.¹ It reduces the duration of treatment and improves patient comfort. The dimensions of the sockets after extraction are often much larger than the diameters of the implants. While gap can occur at any surface of immediate implant, the buccal bone is of particular importance as it is usually thin and has tendency for resorption and soft tissue recession. The horizontal distance (HD)/jumping gap distance (JGD) is the distance between implant and surrounding alveolus.² The surface of implants exhibits spontaneous osseointegration and bone healing when possessing HD of ≤1.5 mm. HD of >1.5 mm affects spontaneous bone healing. In order to resolve this issue, combining various materials like bone grafts with growth factor (GF) rich platelet concentrates has the added benefit of promoting faster and more effective healing.

When used to treat intraosseous periodontal defects, DFDBA has shown considerable improvements in clinical tissue parameters in both soft and hard tissues.³ Bone morphogenic proteins found in the DFDBA encourage local cell division to produce new bone.⁴

The fibrin meshwork structure of A-PRF that results from the polymerisation of the platelets and leukocyte concentration is the factor that influences the release of GF for up to a period of 10 days during the reorganisation of the wound.⁵^,⁶ PRF production protocol at reduced centrifugation speed (1500 rpm for 14 minutes) produces A-PRF. A-PRF favours the release of higher amount of GFs than PRF, which might affect tissue regeneration directly. There hasn't been research yet to evaluate combined effect of A-PRF and DFDBA placement in peri-implant void on hard and soft tissue alterations followed by immediate implant placement. Therefore, an intent of this study is to evaluate the efficiency of combination of A-PRF in with DFDBA placed simultaneously into an extraction socket followed by placement of immediate implant on the clinical and radiological outcomes.

Aim

To evaluate efficacy of A-PRF and DFDBA in implants placed in fresh extraction socket on the clinical and radiological outcomes.

Objectives

1. To evaluate the horizontal and vertical crestal bone changes around immediate implants sockets augmented with A-PRF and DFDBA.
2. To evaluate the changes in the buccolingual dimension of socket around immediate implants augmented with A-PRF and DFDBA.
3. To evaluate the success rate of an immediate implant placed simultaneously with a combination of A-PRF and DFDBA placement.

Methods

Ethical considerations

The study proposal is approved by “Institutional Ethics Committee” with Ref. No. DMIHER (DU)/IEC/2023/577 on 06/02/2023.

Trial registration

Name of registry - Clinical Trial Registry of India

REF No. ‐ REF/2023/03/064371

URL - https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=97508.22015

Submitted to CTRI on ‐ 04/03/23

Sample size calculation

Formula Using Mean difference

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Z_{α} = 1.96

α = Type I error at 5 %

Z_{β} = 0.84 (1 - β) = Power at 80 %

σ = std . dev

Primary Variable (Buccolingual dimention of socket wall)

(Immediate implant placement, difference after 6 months) Mean ± SD. = 0.10 ± 0.09

As per reference articles - Bhombe et al (2022)

N1 = 2^{*} [{(1.96 + 0.84)}^{2} {(0.09)}^{2}] / {(0.10)}^{2} = 13

Total samples required =13 per Group.

The calculation gives the result as 13, thus a round figure of 12 samples will be used for the study. This will be a single arm prospective clinical study.

Study population

In this study, 12 implants will be placed in systemically healthy individuals who have a need for tooth/teeth replacement through implant from the outpatient “Department of Periodontics”.

Inclusion criteria

1. Teeth that require extraction due to fracture of root, residual roots, internal and external resorption, endodontic failures, non-restorable carious lesions, over-retained deciduous teeth.
2. Good oral hygiene, with a full mouth plaque score of less than 25%.
3. Thick gingival biotype.
4. Intact alveolar bony walls appeared both clinically and radiographically.
5. At least 4mm bone must be present below root apex.
6. Bone quality: D1 and D2.
7. The HD should be more than 1.5 mm.

Exclusion criteria

1. Altered health conditions that would interfere with bone healing e.g. diabetic patients, blood disorders, osteoporosis, and people allergic to titanium, etc.
2. Space discrepancies between maxilla-mandible.
3. Bone quality: D3 and D4.
4. Implant site having <2mm of width of keratinized gingiva.
5. Para functional habits.
6. Proclined teeth, mal-aligned or rotated anterior teeth, teeth with interdental spacing.
7. Untreated dental diseases.
8. Debilitating tempromandibular (TMJ) joint pathosis.
9. Habit of smoking, alcohol intake or drug abuse.
10. Pregnant woman, lactating mother.

Only type I extraction sites will be chosen based on the preoperative classification given by Salama and Salama in 1993.⁷ Before the study begins, details about nutritional status, oral hygiene practises, detailed medical history, and periodontal health status will be recorded in a specially designed case history. Patients will be evaluated under good illumination using William’s graduated probe and mouth mirror. They will be informed about the design and purpose of the clinical trial before the study begins, and their written consent will be obtained.

Study design

This study will be conducted over the course of a year. Twelve implants will be placed in individuals with need of extraction of maxillary and/or mandibular teeth. They will be recruited from the outpatient department of “Department of Periodontics and Implantology, Sharad Pawar Dental College, Sawangi, (Meghe)”. Using a two-stage protocol, implant placement will be done into the fresh extraction socket after the socket has been augmented with A-PRF and DFDBA. Three months after the placement of an implant, a second stage surgery will be performed. Following second stage surgery, abutments will be connected and a prosthesis will be placed within 2 to 4 weeks. Before the procedure, 3 months after implant placement, and 6 months following permanent prosthesis the clinical parameters will be evaluated, which include probing depths around implants, the full mouth modified plaque index (FMPI), the modified papillary bleeding index (FMPBI), and implant mobility using the clinical implant mobility scale (CIMS). Cone Beam Computed Tomography (CBCT) will be obtained for preoperative assessment.⁸

Clinical measurements

Primary outcomes

Primary outcome will be the vertical and horizontal crestal bone changes around immediately placed implants.

Secondary outcomes

Secondary outcome will the implant mobiliy.

Clinical indices

Clinical indices will be obtained at three different times: baseline, three months after an implant has been placed, and six months after the final prosthesis. The operator will record the clinical indices for each patient. A mean calculation of these will be obtained for the purpose of assessing the results. The FMPI given by “Turesky – Gilmore – Glickman Modification of Quigley Hein” (1970) will be used to determine oral hygiene status.⁹ The FMPBI given by “Muhlemann HR.” (1977) will be used to evaluate gingival inflammation.¹⁰

Clinical measurements around extraction site

a. Width of keratinized gingiva (WKG): Using a University of North Carolina (UNC 15) probe, the WKG on the buccal aspect will be determined which is the distance between the gingival margin and muco-gingival junction.
b. Gingival biotype: A thin or thick gingival biotype will be determined (Muller et al., 2000).¹¹

Radiographic measurements

CBCT will be used for preoperative diagnosis and evaluation of available bone (volumetric) to guide implant placement. The information from these scans can be used to precisely analyse the paranasal sinuses, craniofacial bones, and also the degree of sinus pneumetization.¹²

Initial therapy

Following a comprehensive examination and diagnosis, a full mouth scaling will be done, followed by oral hygiene instructions. Until an individual achieves a plaque score of less than 1, the plaque control instructions will be repeated. To determine the maxillo-mandibular relationship, diagnostic casts of each individual will be made prior to the surgical phase. CBCT will be obtained for everyone, and clinical photos will be taken periodically throughout the process.

Surgical procedure

Extraction of tooth

Following complete asepsis and the administration of local anaesthesia, sulcular incisions will be made on the buccal and lingual/palatal surfaces of the tooth to be extracted. In order to visualise the bone plates, full thickness mucoperiosteal flaps reflection will be done on the buccal and palatal/lingual aspects.

Atraumatic extraction will be performed to minimise trauma to the alveolus and achieve minimal socket expansion. An initial incision will be made with a Bard Parker surgical blade of no. 12 or 15, followed by the separation of the supracrestal gingival fibres and periodontal ligament on the mesial and distal aspects of the root. The tooth will then be extracted mainly using periotome, or if there is sufficient tooth structure, the tooth may be carefully extracted with extraction forceps.

After the extraction of a tooth, the sockets will be inspected for fractures in the socket walls and then thoroughly debrided. If required, ridge alveoloplasty will be performed to achieve a flat bone surface of sufficient width. The sockets will be curated to induce fresh bleeding. Normal saline will be used to irrigate the extraction sockets, which will then be packed for 5 minutes with gauze soaked in normal saline. To measure the root length of an extracted tooth, UNC 15 probe will be used, while the mesiodistal and buccolingual dimensions of the tooth will be measured with a Vernier Caliper, and these values will be correlated with radiographic findings to determine the diameter and length of an implant.

Placement of an implant

After osteotomy site preparation, implants of appropriate length and diameter will be placed in the recipient site. Implant shoulder would be located at or not more than 1 mm apical to the crestal bone, equating to around 3mm apical to the free gingival margin. The JGD will be measured after the implant placement, and only implants with a gap of 1.5 mm or more will be considered for the study. A-PRF will be prepared by drawing 5 ml of blood from the patient, transferring it to sterile, plain glass-based tubes within 30 seconds, and placing them in a centrifuge machine. Using single-spin centrifugation, it will be centrifuged for 14 minutes at 1500 rpm. Following centrifugation, A-PRF clot will be obtained. DFDBA particles with A-PRF will be placed in the extraction site and will be intimately packed.

At the time of insertion, the primary stability will be checked by recording the insertion torque value. After stabilisation, the buccal flap will be placed around the implant, and simple interrupted suturing will be done to suture it to the lingual/palatal flap. Immediate postoperative radiographs will be taken as a baseline record and to confirm complete seating of the implants.

Second stage surgery

Three months after implant placement, the second stage surgery will be performed. The implants will be uncovered by removing the cover screw and replacing it with a gingival former, allowing guided soft tissue healing around 9-10 days. Patients will be given medication after surgery and continue it for at least 3 days post-surgery.

Prosthetic reconstruction

Abutment connection followed by definitive prosthesis will be carried out 9-10 days after removal of gingival former.

Re-evaluation

Six months after the placement of a definitive prosthesis, a complete re-evaluation will be conducted. Clinical parameters will be evaluated, which include probing measurements around implants, FMPBI, FMPI, and implant mobility with the help of CIMS.¹³^,¹⁴ Radiographic parameters will be assessed using CBCT. Any biological & technical complications will also be examined.

Statistical analysis

The mean and standard deviation (Mean ± SD) values of all the clinical parameters, including FMPI, FMPBI, PPD, buccolingual socket dimension, and radiographic marginal bone level, will be computed. Mean data from the first, third, and sixth months of all patients' treatment will be compared to determine statistical significance. All patients' baseline values will be compared to those at 3 months, and to 6 months after final prosthesis, using Student's paired test. If the probability value (p) is greater than >0.05, the observed difference will be considered statistically insignificant; otherwise, it will be considered significant.

Study status

Patient recruitment will begin in June 2023 and is anticipitated to be completed by June 2024.

Discussion

A clinical study assessed the efficacy of “hydroxyapatite” (HA) coated and “titanium plasma-sprayed” implants placed in fresh extraction sockets with respect to its effect on new bone formation and bone-implant contact.¹⁵ The investigators came to the conclusion that bone regeneration was significantly more effective when “DFDBA” and a “GTR” barrier material were used together than when a barrier membrane was used alone.

In another study, investigators compared immediate implant placement with “DFDBA” to that with “modified HA”.¹⁶ Here, both groups produced outcomes that were equivalent. Around implants, the mean bone level remained steady and even improved.

Presence of periapical infections may present obstacles for immediate implant placement. However, a study assessed an effectiveness of “platelet concentrates” when combine with an “allograft” (DFDBA)¹⁷ on implants placed in extraction sockets with periapical infections. The biomaterials used were meant to fill the JGD. The frequency of outcome measures was assessed at baseline, 3 months, 6 months, and 12 months, which included FMPI, FMBI and gingival aesthetic score. Radiographic parameters were assessed on CBCT at the start of the study and 12 months following implant loading. There were statistically significant differences seen in all periodontal parameter however the gingival aesthetic score greatly improved on the interproximal and midfacial regions. This study also reported an increased implant survival rate in one year.

The various platelet concentrates when combined with allografts are known for their use in managing JGD. Bhombe et al. assessed the combined effect of “PRF matrix” with “DFDBA” in JGD fill.¹⁸ Implant loading was performed three months after implant placement, following two stage protocol. Clinical and radiographic parameters were evaluated at baseline, 3 months, and 6 months. Six months after loading, the implant success was 100%. The authors reported that buccolingual dimensions were preserved, and bone resorption was significantly reduced.

Thus, the purpose of this study is to assess the combined efficacy of A-PRF and DFDBA placed in a fresh extraction socket following immediate implant placement using a two-stage approach. This study plan will be reliable to prove advantages pertaining to improvements in the following parameters, such as fewer surgical procedures required, preservation of sufficient bone height, and improved aesthetic results.

Expected outcomes

The bone fill and bone defect resolution achieved by the augmentation procedures have been proven to be successful. Reduced horizontal bone resorption may be achieved by simultaneous implant placement with bone augmentation. After using A-PRF and DFDBA, we anticipate faster and more effective healing, which will benefit osseointegration and implant stability. The improvement in bone volume, bone height, and bone density will be confirmed by clinical and radiological parameters.

Data availability

Underlying data

No data are associated with this article.

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Evaluation of effectiveness of advanced platelet rich fibrin (A-PRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study’, https://doi.org/10.5281/zenodo.7780095.

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

References

1. Hämmerle CH, Chen ST, Wilson TG Jr: Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets. Int. J. Oral Maxillofac. Implants. 2004; 19(suppl): 26–28.
2. Botticelli D, Bergiundh T, Buser D, et al.: The jumping distance revisited: An experimental study in the dog. Clin. Oral Impl. Res. 2003; 14: 35–42. Publisher Full Text
3. Rummelhart JM, Mellonig JT, Gray JL, et al.: A comparison of freeze-dried bone allograft and demineralized freeze-dried bone allograft in human periodontal osseous defects. J. Periodontol. 1989; 60: 655–663. PubMed Abstract | Publisher Full Text
4. Urist M, Strates B: Bone morphogenic protein. J. Dent. Res. 1971; 50: 1392–1406. Publisher Full Text
5. Ghanaati S, Booms P, Orlowska A, et al.: Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J. Oral Implantol. 2014 Dec; 40(6): 679–689. PubMed Abstract | Publisher Full Text
6. Fujioka-Kobayashi M, Miron RJ, Hernandez M, et al.: Optimized platelet-rich fibrin with the low-speed concept: growth factor release, biocompatibility, and cellular response. J. Periodontol. 2017 Jan; 88(1): 112–121. PubMed Abstract | Publisher Full Text
7. Salama H, Salama M: The role of orthodontic extrusive remodeling in the enhancement of soft and hard tissue profiles prior to implant placement: a systematic approach to the management of extraction site defects. Int. J. Periodontics Restorative Dent. 1993 Aug 1; 13(4): 312–333. PubMed Abstract
8. Jacobs R, Salmon B, Codari M, et al.: Cone beam computed tomography in implant dentistry: recommendations for clinical use. BMC Oral Health. 2018; 18: 88. PubMed Abstract | Publisher Full Text | Free Full Text
9. Turesky S: Gilmore, Glickman: Reduced plaque formation by the chloromethyl analogue of vitamin C. J. Periodontol. 1970; 41: 41–43. PubMed Abstract | Publisher Full Text
10. Mulhemann HR: Psychological and chemical mediators of gingival health. J. Prev. Dent. 1977; 4: 6–17.
11. Muller HP, Heinecke A, Schaller N, et al.: Masticatory mucosa in subjects with different periodontal phenotypes. J. ClinPeriodontol. 2000; 27: 621–626. Publisher Full Text
12. Dangore-Khasbage, Bhowate R: Utility of the morphometry of the maxillary sinuses for gender determination by using computed tomography. Dent. Med. Probl. 2018; 55(4): 411–417. PubMed Abstract | Publisher Full Text
13. Mombelli H: Monitoring disease around dental implants during supporative periodontal treatment. Periodontology. 2000; 12(12): 60–68. Publisher Full Text
14. Misch CE: The implant quality scale: A clinical assessment of the health disease continuum. Oral Health. 1998; 15: 15–25.
15. Gher M, Quintero G, Assad D, et al.: Bone Grafting and Guided Bone Regeneration for Immediate Dental Implants in Humans. J. Periodontol. 1994; 65: 881–891. Publisher Full Text
16. Viswambaran M, Arora V, Tripathi RC, et al.: Clinical evaluation of immediate implants using different types of bone augmentation materials. Med. J. Armed Forces India. 2014 Apr 1; 70(2): 154–162. PubMed Abstract | Publisher Full Text | Free Full Text
17. Medikeri RS, Meharwade V, Wate PM, et al.: Effect of PRF and Allograft Use on Immediate Implants at Extraction Sockets with Periapical Infection—Clinical and Cone Beam CT Findings. Bull. Tokyo Dent. Coll. 2018; 59(2): 97–109. PubMed Abstract | Publisher Full Text
18. Bhombe KR, Bajaj P, Mundada B, et al.: Combined Effect of Platelet-Rich Fibrin Matrix (PRFM) and Demineralized Freeze-Dried Bone Allograft (DFDBA) in Immediate Implant Placement: A Single-Arm Clinical Trial. Cureus. 2022 Sep 29; 14(9). Publisher Full Text

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Version 1

VERSION 1 PUBLISHED 25 Apr 2023

Author details Author details

¹ Department of Periodontics and Implantology, Datta Meghe Institute of Higher Education & Research, Sawangi (Meghe), Wardha, Maharashtra, 442001, India

Sneha Dare
Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Pavan Bajaj
Roles: Project Administration, Supervision

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 25 Apr 2023, 12:440

https://doi.org/10.12688/f1000research.133342.1

Copyright

© 2023 Dare S and Bajaj P. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Dare S and Bajaj P. Evaluation of effectiveness of advanced platelet rich fibrin (A-PRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study [version 1; peer review: 2 not approved]. F1000Research 2023, 12:440 (https://doi.org/10.12688/f1000research.133342.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

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Reviewer Report 06 Jan 2025

Seong-Gon Kim, Gangneung-Wonju National University, Gangneung, South Korea

Not Approved

https://doi.org/10.5256/f1000research.146321.r349264

The article titled "Evaluation of Effectiveness of Advanced Platelet Rich Fibrin (A-PRF) with Demineralized Freeze-Dried Bone Allograft (DFDBA) Placed into Fresh Extraction Sockets with Immediate Implant Placement: A Clinical and Radiographic Study" outlines a research plan to assess the combined ... Continue reading

The article titled "Evaluation of Effectiveness of Advanced Platelet Rich Fibrin (A-PRF) with Demineralized Freeze-Dried Bone Allograft (DFDBA) Placed into Fresh Extraction Sockets with Immediate Implant Placement: A Clinical and Radiographic Study" outlines a research plan to assess the combined efficacy of A-PRF and DFDBA in immediate implant placement. While the study presents an intriguing topic, it reflects the characteristics of a preliminary protocol rather than a completed investigation.

The abstract provides a broad overview of the study, emphasizing the potential benefits of immediate implant placement with augmentation using A-PRF and DFDBA. However, the background information appears repetitive and overly detailed, lacking conciseness. The inclusion of "expected results" highlights the absence of experimental data and reinforces the speculative nature of the claims.

The methodology details a one-year clinical study involving 12 implants placed in systemically healthy individuals. It describes the procedural steps, including implant placement into fresh extraction sockets, augmentation, and follow-up surgeries. The outcomes focus on crestal bone changes and implant stability, measured through radiographic and clinical evaluations. Despite this comprehensive plan, the methodology remains unexecuted, as the study lacks results or observational data. While ethical approval and trial registration are mentioned, the absence of implementation diminishes the study’s completeness.

The article exhibits inconsistencies in its sample size calculation. Although the formula suggests 13 samples, only 12 are planned, with no rationale provided. Furthermore, the conclusions rely heavily on anticipated results, proposing that augmentation with A-PRF and DFDBA will enhance healing and reduce bone resorption. These assertions are speculative and unsupported by data. The lack of visual evidence, such as radiographic or clinical images, further weakens the study’s claims.

The references cited include outdated sources, with only one from the past five years. This limits the study’s relevance in addressing current research gaps. Additionally, the absence of results and visual data hinders the ability to evaluate its potential contributions to implantology.

To enhance the article's scientific value, the study must first be conducted, and results presented. The background should be condensed to focus on the research gap and relevance of A-PRF and DFDBA. The sample size calculation requires clarification and consistency. Recent literature should be incorporated to reflect contemporary understanding. Supporting data, including images and detailed results, are necessary for validation. Conclusions should be reframed to reflect findings rather than anticipated outcomes.

In its current form, the article serves as a preliminary study protocol with potential for future contributions to implantology. However, the lack of execution and supporting evidence limits its credibility and applicability.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: tissue engineering, oral and maxillofacial surgery

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report 12 Jun 2024

Gustavo Fernandes, Periodontics and Oral Medicine Department, A. T. Still University - Missouri School of Dentistry & Oral Health, St. Louis, Missouri, USA

Not Approved

https://doi.org/10.5256/f1000research.146321.r273933

Dear authors,
I evaluated the study titled "Evaluation of effectiveness of advanced platelet rich fibrin (APRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study".

... Continue reading

Dear authors,
I evaluated the study titled "Evaluation of effectiveness of advanced platelet rich fibrin (APRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study".

MAJOR CONCERNS:

This is a study that presented no x-rays and pictures, has a lack of standard and presentation.
The type of article was not presented in the title (I suggest to include it in the title, to clarify the understanding for the reader).
18 references were included and only one out of them was published in the last 5 years. I recommend to update all references.
The sample size calculation used a wrong variable to calculate the number of individuals to be included; revise and adjust it. Moreover, if the result found was 13, why the authors included 12?
"Study design: This study will be conducted over the course of a year." The IRB was approved in "06/02/2023". If the results are for 1 year, why the authors presented results for only 6 months?
Double-check all points of the guidelines that the authors used, please.
I did not find the Results section (there are no results in the article)
Why "Expected outcomes"?

After raised those points, it is not possible to support the indexed.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Periodontics, Biomaterials, Dental implants.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Version 1 25 Apr 23	read	read

Gustavo Fernandes, A. T. Still University - Missouri School of Dentistry & Oral Health, St. Louis, USA
Seong-Gon Kim, Gangneung-Wonju National University, Gangneung, South Korea

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06 Jan 2025 | for Version 1

Seong-Gon Kim, Gangneung-Wonju National University, Gangneung, South Korea

2 Views Cite this report Responses(0)

Not Approved

The article titled "Evaluation of Effectiveness of Advanced Platelet Rich Fibrin (A-PRF) with Demineralized Freeze-Dried Bone Allograft (DFDBA) Placed into Fresh Extraction Sockets with Immediate Implant Placement: A Clinical and Radiographic Study" outlines a research plan to assess the combined efficacy of A-PRF and DFDBA in immediate implant placement. While the study presents an intriguing topic, it reflects the characteristics of a preliminary protocol rather than a completed investigation.

The abstract provides a broad overview of the study, emphasizing the potential benefits of immediate implant placement with augmentation using A-PRF and DFDBA. However, the background information appears repetitive and overly detailed, lacking conciseness. The inclusion of "expected results" highlights the absence of experimental data and reinforces the speculative nature of the claims.

The methodology details a one-year clinical study involving 12 implants placed in systemically healthy individuals. It describes the procedural steps, including implant placement into fresh extraction sockets, augmentation, and follow-up surgeries. The outcomes focus on crestal bone changes and implant stability, measured through radiographic and clinical evaluations. Despite this comprehensive plan, the methodology remains unexecuted, as the study lacks results or observational data. While ethical approval and trial registration are mentioned, the absence of implementation diminishes the study’s completeness.

The article exhibits inconsistencies in its sample size calculation. Although the formula suggests 13 samples, only 12 are planned, with no rationale provided. Furthermore, the conclusions rely heavily on anticipated results, proposing that augmentation with A-PRF and DFDBA will enhance healing and reduce bone resorption. These assertions are speculative and unsupported by data. The lack of visual evidence, such as radiographic or clinical images, further weakens the study’s claims.

The references cited include outdated sources, with only one from the past five years. This limits the study’s relevance in addressing current research gaps. Additionally, the absence of results and visual data hinders the ability to evaluate its potential contributions to implantology.

To enhance the article's scientific value, the study must first be conducted, and results presented. The background should be condensed to focus on the research gap and relevance of A-PRF and DFDBA. The sample size calculation requires clarification and consistency. Recent literature should be incorporated to reflect contemporary understanding. Supporting data, including images and detailed results, are necessary for validation. Conclusions should be reframed to reflect findings rather than anticipated outcomes.

In its current form, the article serves as a preliminary study protocol with potential for future contributions to implantology. However, the lack of execution and supporting evidence limits its credibility and applicability.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

tissue engineering, oral and maxillofacial surgery

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report

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12 Jun 2024 | for Version 1

Gustavo Fernandes, Periodontics and Oral Medicine Department, A. T. Still University - Missouri School of Dentistry & Oral Health, St. Louis, Missouri, USA

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Not Approved

Dear authors,
I evaluated the study titled "Evaluation of effectiveness of advanced platelet rich fibrin (APRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study".

MAJOR CONCERNS:

This is a study that presented no x-rays and pictures, has a lack of standard and presentation.
The type of article was not presented in the title (I suggest to include it in the title, to clarify the understanding for the reader).
18 references were included and only one out of them was published in the last 5 years. I recommend to update all references.
The sample size calculation used a wrong variable to calculate the number of individuals to be included; revise and adjust it. Moreover, if the result found was 13, why the authors included 12?
"Study design: This study will be conducted over the course of a year." The IRB was approved in "06/02/2023". If the results are for 1 year, why the authors presented results for only 6 months?
Double-check all points of the guidelines that the authors used, please.
I did not find the Results section (there are no results in the article)
Why "Expected outcomes"?

After raised those points, it is not possible to support the indexed.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Periodontics, Biomaterials, Dental implants.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

Respond to this report

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[16] 16. Viswambaran M, Arora V, Tripathi RC, et al.: Clinical evaluation of immediate implants using different types of bone augmentation materials. Med. J. Armed Forces India. 2014 Apr 1; 70(2): 154–162. PubMed Abstract | Publisher Full Text | Free Full Text

[17] 17. Medikeri RS, Meharwade V, Wate PM, et al.: Effect of PRF and Allograft Use on Immediate Implants at Extraction Sockets with Periapical Infection—Clinical and Cone Beam CT Findings. Bull. Tokyo Dent. Coll. 2018; 59(2): 97–109. PubMed Abstract | Publisher Full Text

[18] 18. Bhombe KR, Bajaj P, Mundada B, et al.: Combined Effect of Platelet-Rich Fibrin Matrix (PRFM) and Demineralized Freeze-Dried Bone Allograft (DFDBA) in Immediate Implant Placement: A Single-Arm Clinical Trial. Cureus. 2022 Sep 29; 14(9). Publisher Full Text

Evaluation of effectiveness of advanced platelet rich fibrin (A-PRF) with demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with immediate implant placement: A clinical and radiographic study

Abstract

Keywords

Introduction

Aim

Objectives

Methods

Ethical considerations

Trial registration

Study design

Clinical measurements

Clinical measurements around extraction site

Radiographic measurements

Initial therapy

Surgical procedure

Re-evaluation

Statistical analysis

Study status

Discussion

Expected outcomes

Data availability

Underlying data

Reporting guidelines

References

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