[version 1; peer review: 1 approved with reservations]
No competing interests were disclosed.
Antibiotic resistance of bacteria to medications can be resolved using nanotechnology. Resistance to antibiotic mechanisms, such as regulation of permeability, multi-drug efflux pumps, antibiotic disintegration, and target area attraction, are dealt with by nanoparticles. These NPs are composed of Ag and Cu as heavy metals. Being both an essential nutrient as well as an especially hazardous matter, copper represents the two poles of the survival range for microorganisms. Because copper fittings and work surfaces are capable of eliminating methicillin-resistant
Periodontitis is a complex microbial disease with dental plaque as its primary etiological agent. The intricate connections of the biofilm with the host inflammatory reaction as a disease expression leads to a reduction in bone and connective tissue destruction in chronic periodontitis.
It is likely that certain types of periodontal disease affect more than 90% of the population. In patients with periodontitis, mechanical therapy alone sometimes fails to remove periodontopathic microorganisms. Whenever gingival inflammation continues or reverts, it leads to loss of periodontal attachment.
The local drug is retained in the periodontal pocket, which acts as a pool for periodontal pathogens. Various local drug delivery agents, such as chlorhexidine gluconate, doxycycline hyclate, minocycline hydrochloride, and tetracycline fibers, have been approved for use in periodontal pockets.
Nanotechnology provides an avenue for combating antibiotic-resistant microorganisms
To measure the clinical outcomes of a local drug delivery agent (copper nanoparticle gel against chlorhexidine gel) with scaling and root planing in patients with periodontitis.
To assess the clinical efficacy using the Papillary Bleeding Index (PBI), Modified Plaque Index (PI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL) after scaling and root planing with copper nanoparticles and/or chlorhexidine gel in patients with periodontitis.
Copper nanoparticles (particle size 30-50nm) were procured from the Nano Research Laboratory, Jharkhand, India, provided with the safety data sheet and analysis.
Copper nanoparticles (0.005% w/v) were added to (1% w/v) weighed Carbopol 934 (soaked overnight in distilled water at 4°C) and mixed thoroughly. Methyl paraben (0.18% w/v) and propyl paraben (0.02% w/v) were added as preservatives and 1N NaOH solution was added drop wise to the above dispersion until it formed gel. The gel was refrigerated in airtight containers for further studies. The gel possessed a smooth, homogeneous texture and was free of gritty particle with transparent colour.
The patients were willing to provide
Power analysis was performed using G*Power, version 3.0.1 (Franz Faul University, Kiel, Germany). The total determined minimum sample size was 38 rounded to 40 individuals (i.e., 20 individuals in each research subgroup) with an effect size of 0.95 and a level of significance of 0.5. See
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The auxiliary staff will hand over the patient’s material after reading the randomization sheet. The study’s details, randomization code, and information regarding the allocation of treatments, such as tests or products, will be provided to the auxiliary staff, the randomization sheet. After reviewing the randomization sheet, the auxiliary staff dispensed the material to the patient.
At the screening visit, periodontal examination of all the eligible patients were carried out and impressions were made for fabrication of stent to ensure the reproducibility of measurements during the subsequent examinations. Occlusal stents for the repositioning of probe will be fabricated with self-cured acrylic resin on the study model of the patient to cover the occlusal as well as coronal one third of the buccal and lingual surfaces of the teeth involved. Vertical grooves were made to guide the probe penetration vertically in the same plane everytime it was inserted for recording the measurements. All the clinical parameters were recorded by a single examiner.
The 40 subjects were divided into two groups. Group A - scaling and root planing followed by copper nanoparticles gel application in residual pockets, Group B - Scaling and root planing followed by chlorhexidine gel application in residual pockets using a blunt canula till the pocket is overfilled with the gel. The sites were covered with coe-pack to retain the material in the pocket as well as to prevent the ingress of oral fluids. The pack was removed after 7 days.
The clinical outcomes will be measured in terms of Papillary Bleeding Index (PBI) (by Saxer and Muhlemann 1975), Modified Plaque Index (MPI) (by Turesky et al modification of the Quigley-Hein Index1970), Probing Pocket Depth (PPD), Relative Attachment Level (RAL) at baseline, 1 month and 3 month. Patients were asked to maintain oral hygiene and no other chemical plaque control measures to use during the study period. Patients were asked to report immediately on developing any untoward reactions. Expected adverse effects were hypersensitivity and local reaction.
At multiple points around the entire circumference of the tooth, probing pocket depth was measured in millimeters from the free gingival margin to the base of the sulcus. The floor of the sulcus was gently inspected horizontally using a periodontal probe. The UNC-15 probe was used to carefully measure the relative attachment level parallel to the long axis of the tooth until resistance was detected. The nearest millimeter was recorded from the bottom end of the occlusal stent as a reference point to the base of the pocket.
The statistical computation and collation of all findings will be accomplished using SPSS software (version 26© SPSS, Chicago, IL). The means and standard deviations of the data will be calculated. When P<0.05, all clinical parameters (PBI, MPI, PPD, and CAL) will be considered statistically significant.
The implementation of nanotechnology to enhance the delivery of medications for periodontal diseases has been validated by research conducted over the last ten years. Because nanoparticulates may encompass multifunctional elements, alter drug release kinetics, are target-specific, and respond to an array of external signaling sources, they present a unique potential in treating periodontal diseases. The application of nanotechnology in drug delivery has been demonstrated to be rapid and effective. To advance nanotechnology-assisted drug delivery from basic research to clinical practice, a number of issues need to be resolved. Partnering experts from multiple disciplines is essential for turning breakthrough laboratory findings into therapeutic products that might be sold successfully.
Ongoing.
The Subjects will come from the Department of Periodontology and Implantology at Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Sawangi, Wardha. The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Ethics Committee (IEC) (DMMIMS (DU)/IEC/2021/581) on 1/10/2021. The Central Ethics Committee on Human Research (C.E.C.H.R) ethical standards were followed for medical research involving human subjects. This Randomized Control Clinical Trial is registered under Clinical Trial Registry of India (
The patients were willing to provide written informed consent and cooperate with the protocol.
No data are associated with this article.
In the manuscript entitled: “Evaluation of clinical efficacy of scaling and root planing with copper nanoparticles gel and/or chlorhexidine gel in patients with periodontitis: A randomized control trial" the author aimed to assess the clinical outcomes of a local drug delivery agent (copper nanoparticle gel against chlorhexidine gel) with scaling and root planing in patients with periodontitis.
The author found that Because copper fittings and work surfaces are capable of eliminating methicillin-resistant S. aureus (MRSA) to prevent cross-contamination, they act as an additional obstacle. Additional research is needed, as the mode of action of nanoparticles is not fully understood. Existing information concerning NPs encourages further research to explore their use in the control of dental infections.
Major comments:
In general, the idea and innovation of this study regards the analysis of the link between periodontitis and treatment is interesting and novel because the role these aspects in medicine are validated but further studies on this topic could be an innovative issue in this field could be open a creative matter of debate in literature by adding new information. Moreover, there are few reports in the literature that studied this interesting topic with this kind of study design.
The study was well conducted by the authors; However, there are some concerns to revise that are described below.
The introduction section resumes the existing knowledge regarding the important factor linked with the relationship between periodontitis and related mediators.
However, as the importance of the topic, the reviewer strongly recommends, before a further re-evaluation of the manuscript, to update the literature through read, discuss and cites in the references with great attention all of those recent interesting articles, that helps the authors to better introduce and discuss the relationship and impact of chlorexidine and systemic health on oral and periodontal tissues mediators: Ref 1 and 2
The authors should be better specified, at the end of the introduction section, the rationale of the study and the aim of the study. In the central section, should better clarify inclusions and exclusions criteria of the selected sample.
Please better state the results obtained in the abstract.
The discussion section appears well organized with the relevant paper that support the conclusions, even if the authors should better discuss the relationship regarding the by periodontitis in and risk of oxidative stress evolution linked with inflammation. The conclusion should reinforce in light of the discussions.
In conclusion, I am sure that the authors are fine clinicians who achieve very nice results with their adopted protocol. However, this study, in my view does not in its current form satisfy a very high scientific requirement for acceptance and requests a revision before a further re-evaluation of the manuscript.
Minor Comments:
Abstract:
Better formulate the abstract section by better describing the aim of the study Please refer to major comments Please add a specific sentence that clarifies the results obtained in the first part of the discussion
Introduction:
Discussion
Is the study design appropriate for the research question?
Partly
Is the rationale for, and objectives of, the study clearly described?
Partly
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
periodontology
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.