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Research Article

Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial

[version 1; peer review: 1 approved, 2 approved with reservations]
Safeya AbdurRahman
https://orcid.org/0000-0003-1803-9029
1, Saied M. Abdel Aziz
https://orcid.org/0000-0002-1035-0093
1, Shaimaa I. Gawdat1, Ahmed M. AbdalSamad
https://orcid.org/0000-0003-4087-4282
2
Safeya AbdurRahman
https://orcid.org/0000-0003-1803-9029
1, Saied M. Abdel Aziz
https://orcid.org/0000-0002-1035-0093
1, Shaimaa I. Gawdat1, Ahmed M. AbdalSamad
https://orcid.org/0000-0003-4087-4282
2
PUBLISHED 26 Jul 2019
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

Abstract

Background: A randomized clinical trial was conducted to compare the postoperative pain following endodontic treatment of necrotic teeth with apical periodontitis. Treatments were performed in multiple visits with application of triple antibiotic paste interappointment dressing or single visit without interappointment dressing.
Methods: In total 44 participants were assigned randomly into two groups. Group A: multiple visit endodontic treatment with triple antibiotic paste interappointment dressing; group B: single visit endodontic treatment without interappointment dressing. Postoperative pain of participants was assessed after 24, 48, 72 hours and one week using numerical rating scale.
Results: No statistically significant difference was found in postoperative pain after 24, 48, 72 hours and one week between the two groups.
Conclusion: Triple antibiotic paste as an interappointment dressing in multiple visits endodontic treatment was not proved to reduce the postoperative pain compared to a single visit in patients with necrotic teeth with apical periodontitis who did not have an interappointment dressing.
Trial registration: clinicaltrials.gov, NCT02947763. Date: 28th October 2016.

Keywords

Apical periodontitis, multiple visits, triple antibiotic paste, interappointment dressing

Corresponding author: Safeya AbdurRahman
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2019 AbdurRahman S et al. 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: AbdurRahman S, Abdel Aziz SM, Gawdat SI and AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial [version 1; peer review: 1 approved, 2 approved with reservations]. F1000Research 2019, 8:1203 (https://doi.org/10.12688/f1000research.19936.1) First published: 26 Jul 2019, 8:1203 (https://doi.org/10.12688/f1000research.19936.1) Latest published: 26 Jul 2019, 8:1203 (https://doi.org/10.12688/f1000research.19936.1)

Introduction

Apical periodontitis (AP) arises primarily by continuous bacterial irritation from the root canals1. AP significantly reduces the endodontic success rate2. Therefore, treatment of AP should aim to completely eliminate the underlying root canal infection3, either by chemomechanical preparation or placement of an interappointment dressing4.

Recent systematic reviews found that multiple visits with calcium hydroxide did not improve postoperative pain and flare-up and radiographic healing compared to single visit endodontic treatment without interappointment dressing5–8. Consequently, the search for a better antimicrobial alternative is required9. Previously, triple antibiotic paste (TAP) has been shown to effectively reduce the bacterial load in necrotic teeth10.

The aim of the present study was to compare the postoperative pain following endodontic treatment, of necrotic teeth having apical periodontitis, either performed in single visit or in multiple visits with application of triple antibiotic paste interappointment dressing.

Methods

Trial design

The study was registered on clinical trials.gov and the registration number is NCT02947763.

The protocol was approved by the Committee of Ethics, Faculty of Dentistry, Cairo University, Egypt (approval no 16562). Participants were asked to sign a printed informed consent that explained the study aim, alternative treatments to endodontic treatment, and the investigator’s instructions.

The trial design of this study was a parallel, randomized, clinical design with allocation ratio 1:1. This article follows the CONSORT 2010 statement and a copy of the CONSORT checklist can be found in the Data availability section.

The study began in November 2016 and was completed in February 2018.

Sample size calculation

Prior data11 indicated that standard deviation of pain score was 20.3. If the true difference in the intervention and control is 20.6, we should study 16 in each group to be able to reject the null hypothesis that the population means of the intervention and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis was 0.05. The size of the sample was increased to 22 per group to correct for non-parametric usage and to substitute for any drop-out.

Participants

In total, 44 adults, medically-free with an age range of 16–55 years were selected for the study. All had a necrotic tooth with a periapical lesion confirmed radiographically (minimum size 2 × 2 mm). The participants were enrolled by SA.

Exclusion criteria included teeth previously accessed or endodontically treated; vital or necrotic teeth without periapical lesion; patients allergic to metronidazole, ciprofloxacin, or doxycycline or those with significant medical conditions; patients who took analgesic tablets before treatment up to 12 hours previously; and pregnant women.

Treatment procedures

The teeth were tested with an electric pulp test (Denjoy DY310 Dental Pulp Tester; Denjoy, Henan, China) to determine pulp sensitivity. Radiographs were taken using a photo stimulable phosphor plate wireless sensor (SOREDEX, DIGORA) to detect periapical lesions.

Preoperative pain was recorded using a numerical rating scale (NRS) where 0 indicates no pain and 10 indicates pain as terrible as it could be12. Pain intensity was categorized into either: none (0); mild (1–3); moderate (4–6); and severe (7–10)13.

Local anesthesia was administered if needed (Ubistesin™ Articaine HCl 4% & Adrenaline 1:100,000 3M Australia). Isolation of the tooth with rubber dam and preparation of access cavity was performed and the root canal was instrumented by hybrid technique. Coronal shaping was performed with Gates-Glidden drills (MANI, Japan) sizes 4, 3 and 2. Working length was measured using apex locator (J Morita USA) and ascertained using radiograph, where it was set 1 mm away from the radiographic apex. The apical part was instrumented using stainless steel K-files (MANI, Japan); the master apical file size was set 3–4 sizes larger than the initial file. The middle part was instrumented using 3–5 stainless steel H-files.

Irrigation was done using sodium hypochlorite 2.6% (Clorox®, Egypt), using plastic disposable syringe with needle gauge 27, between successive instruments. Lubrication was done using EDTA gel (QMETA, Korea). Final irrigation was done with 5 ml 17% EDTA solution to remove the smear layer (17% EDTA solution, Prevest DenPro Limited, India). The final wash was done using saline. Master cone-fit radiograph was taken to ensure proper length and preparation. The canals were dried with paper points.

Randomization

At this step, the participants were divided randomly into two groups with a table of random numbers from 1 to 44 generated by SMA using a freely available computer program with n=22/group. The allocation table was kept with an investigator not involved with participant enrollment (SIG). Numbers from 1 to 44 were written on 44 pieces of paper folded eight-times. Each paper was placed separately in a closed opaque envelope. Each participant was asked to pick one of the envelopes and the participant was assigned to the groups based on the number in the envelope.

Group A: multiple (two) visit endodontic treatment with triple antibiotic paste interappointment dressing; group B: single visit endodontic treatment without interappointment dressing.

For group A, triple antibiotic paste (ciprofloxacin, metronidazole, and doxycycline mixed with saline) was prepared and 1 mL of the mixed paste was placed into the canals with a 20-gauge needle of sterile plastic syringe. A sterile cotton pellet was placed, and glass ionomer was placed (Riva Self Cure, Australia). Preparation of the triple antibiotic paste followed the protocol of a previous study14, using ciprofloxacin 250 mg tablets (EPICO, Egypt), metronidazole 500 mg tablets (Aventis, Egypt) and doxycycline 100 mg capsules (Pfizer, Egypt). The powder content of doxycycline capsule was placed in a sterile mortar. In the same mortar, a tablet of metronidazole and a tablet of ciprofloxacin were crushed and all are mixed with saline to a creamy paste. A second appointment was scheduled after at least 7 days. Under rubber dam isolation, the interappointment dressing was removed by H-files and 2.6% sodium hypochlorite and 17% EDTA irrigation followed by saline final wash. Then, obturation was performed using cold lateral condensation technique with resin sealer (ADSEAL, META, Korea). After obturation, glass ionomer was placed to seal the access cavity till final restoration.

For group B, no interappointment dressing was applied and endodontic treatment was ended in the same visit without placement of interappointment dressing. Obturation and sealing of access cavity were performed as in group A.

Outcomes

Primary outcomes. Postoperative pain at 24, 48, 72 hours and one week after instrumentation (first visit of Group A and the single visit of Group B); recorded by the participants using NRS in a pain diary.

Secondary outcomes. Incidence of analgesic intake and number of tablets consumed in case of presence of moderate or severe postoperative pain. Participants were instructed to take one tablet of Ibuprofen 400 mg (NOVARITIS, Canada) every 6 hours and to report the number of tablets consumed.

Blinding

The operator was blinded until the end of instrumentation until she saw the number of the envelope, then the operator either administered the interappointment dressing in group A or ended the endodontic treatment in a single visit (group B). Blinding of the operator to the end of treatment was difficult as there was only a single operator (SA). The participant did not know whether endodontic treatment was done in multiple or single visit; as another appointment was given to all participants whether to complete the endodontic treatment in Group A or for follow-up in Group B. The data analyst was blinded to the group assignment.

Statistical analysis

All the data was collected and tabulated. Statistical analysis was performed by Microsoft Office 2013 (Excel) and statistical package SPSS version 22. The significance level was set at p-value ≤ 0.05. Non-parametric data was summarized as minimum, maximum and median. Chi-squared test was used to compare the incidence of studied parameters and Mann-Whitney test for analysis of severity of pain15.

Results

After enrollment of 78 patients, only 44 participants were included (Figure 1). The age, gender, and preoperative pain did not differ significantly between the two groups; all participants in the two groups had preoperative no-to-mild pain (Table 1).

233ed38f-3212-447a-bf7d-b5933d2324db_figure1.gif

Figure 1. Consort 2010 flow diagram of the study design.

Table 1. Demographic data and preoperative pain of the two groups.

Group A*
(n=22)		Group B♣
(n=22)		p-value
Age (years) mean ± SD31.27±13.537.9±10.30.07
Gender [n (%)]
  Women
  Men
18 (81.8%)
4 (18.2%)
17 (77.2%)
5 (22.8%)
0.7
Preoperative pain (NRS)
  Median
  Range
0
0–3
0
0–3
0.165
Preoperative pain incidence [n (%)]
  No pain
  Mild
18 (81.4%)
4 (18.6%)
14 (63.6%)
8 (36.4%)
0.175

*Multiple visits group; ♣ Single visit group; NRS = numerical rating scale; SD= standard deviation.

The data of the postoperative pain are shown in Table 2. There was no statistically significant difference between the two tested groups, either in the intensity nor the incidence of different pain categories. In both groups, there was a significant decrease in the incidence of pain at different follow-up periods (p < 0.05; Table 3).

Table 2. Incidence and intensity of postoperative pain of the two groups.

PainGroup A*
(n=22)		Group B♣
(n=22)		p-value
After 24 hours
Intensity (NRS)
  Median
  Range
0
0–9
0
0–10
0.878
Incidence [n (%)]
  No pain
  Mild
  Moderate
  Severe
15 (68.2%)
3 (13.6%)
0 (0%)
4 (18.2%)
14 (63.6%)
5 (22.7%)
2 (9.1%)
1 (4.5%)
0.228
After 48 hours
Intensity (NRS)
  Median
  Range
0
0–8
0
0–7
0.452
Incidence [n (%)]
  No pain
  Mild
  Moderate
  Severe
16 (72.7%)
2 (9.1%)
3 (13.6%)
1 (4.5%)
18 (81.8%)
2 (9.1%)
1 (4.5%)
1 (4.5%)
0.773
After 72 hours
Intensity (NRS)
  Median
  Range
0
0–4
0
0–3
0.962
Incidence [n (%)]
  No pain
  Mild
  Moderate
  Severe
20 (90.9%)
1 (4.5%)
1 (4.5%)
0 (0%)
20 (90.9%)
2 (9.1%)
0 (0%)
0 (0%)
0.513
After one week
Intensity (NRS)
  Median
  Range
0
0–0
0
0–0
1
Incidence [n (%)]
  No pain
  Mild
  Moderate
  Severe
22 (100%)
0 (0%)
0 (0%)
0 (0%)
22 (100%)
0 (0%)
0 (0%)
0 (0%)
1

*Multiple visits group; ♣ Single visit group. NRS=numerical rating score.

Table 3. Incidence of pain at different time intervals for each group.

Preoperative24hrs48hrs72hrs1 weekp-value
Group A*
n
%
4
(18.18)
7
(31.8)
6
(27.2)
2
(9.1)
0
(0)
0.032
Group B♣
n
%
8
(36.3)
8
(36.3)
4
(18.18)
2
(9.1)
0
(0)
0.005

* Multiple visits group; ♣ Single visit group.

There was no statistically significant difference between the two tested groups regarding the incidence of analgesic intake and number of analgesics tablets taken by the participants (p > 0.05; Table 4).

Table 4. Incidence of analgesic intake and number of analgesics tablets of the two groups.

Group A*
n=22		Group B♣
n=22		p-value
Incidence of analgesic intake
n
%		4
18.1		3
13.6		0.68
No of tablets
Median
Minimum
Maximum
Total		0
0
2
7		0
0
4
7		0.74


1

*Multiple visits group; ♣ Single visit group.

Discussion

Presence of AP decreases the endodontic success rate, regarding postoperative pain and radiographic healing, by about 10%–15%2,16. Maximum removal of the bacteria and irritants causing AP is essential to achieve better prognosis17. Placement of inter-appointment dressing has been previously recommended to completely disinfect the root canal system4.

TAP has been found to remain active for 30 days18 and shows better antibacterial efficacy than calcium hydroxide in previous in-vitro studies18–28. TAP has been used clinically in case reports and series to treat cases with large periapical lesions, when the use of calcium hydroxide cannot eliminate the symptoms29–32. Moreover, previous randomized clinical trials found that TAP is better than calcium hydroxide, as an intracanal medicament, both clinically and radiographically33–35.

In the present study, the intensity and the incidence at different pain categories did not differ statistically to a significant level (age, gender and preoperative pain were similarly distributed among both groups). This finding is in accordance to the results of previous studies comparing single visit versus multiple visits with calcium hydroxide36–41. During a previous literature search, the authors found no similar studies comparing single visit versus multiple visits with TAP.

In our study, the median postoperative pain of multiple visits group (with TAP) at all follow-up periods was 0 and the incidence of moderate and severe pain ranged from 18.2% to 0%. These results are comparable to the results of previous studies. Pai et al.35 found no interappointment flare-up in the group treated with TAP after 1, 2, 3, 7, and 14 days (in diabetic patients). Prasad et al.33 found that the mean of postoperative pain after one week was 0.86, while Bilgi et al.42 found that the mean of postoperative pain after 24 and 48 hours was 0.08.

In the present study, nearly 95% of the participants were asymptomatic after 72 hours postoperatively. Previous studies found that severe postoperative pain is reduced to a mild pain during this period of time43,44.

Within the conditions of this study, it could be concluded that postoperative pain was similar after performing endodontic treatment in multiple visits with triple antibiotic paste interappointment dressing or in a single visit.

Data availability

Underlying data

Figshare: Postoperative Pain after Single versus Multiple Visits Endodontic Treatment of Necrotic Teeth with Apical Periodontitis with Triple Antibiotic Paste: A Randomized Clinical Trial. Dataset demographic data and postoperative pain, https://doi.org/10.6084/m9.figshare.8797592.v145

Reporting guidelines

Figshare: CONSORT checklist, https://doi.org/10.6084/m9.figshare.8797592.v145

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

Grant information

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

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AbdurRahman S, Abdel Aziz SM, Gawdat SI and AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial [version 1; peer review: 1 approved, 2 approved with reservations]. F1000Research 2019, 8:1203 (https://doi.org/10.12688/f1000research.19936.1)
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 26 Jul 2019
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Reviewer Report 27 Jan 2020
A. R. Vivekananda Pai, Department of Conservative Dentistry and Endodontics, Faculty of Dentistry, Melaka-Manipal Medical College (Manipal Academy of Higher Education [MAHE]), Malacca City, Malaysia 
Htoo Htoo Kyaw Soe, Department of Community Medicine, Melaka-Manipal Medical College (Manipal Academy of Higher Education [MAHE]), Malacca City, Malaysia 
Approved with Reservations
VIEWS 11
https://doi.org/10.5256/f1000research.21880.r51772
Abstract:

Background:

- Suggested grammatical/formatting corrections:

1) Page no. 1, Paragraph no. 1, Sentence line no. 4:
  • Stated as: “dressing or single visit without interappointment dressing.”
  • Suggested
... Continue reading
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HOW TO CITE THIS REPORT
Pai ARV and Kyaw Soe HH. Reviewer Report For: Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial [version 1; peer review: 1 approved, 2 approved with reservations]. F1000Research 2019, 8:1203 (https://doi.org/10.5256/f1000research.21880.r51772)
The direct URL for this report is:
https://f1000research.com/articles/8-1203/v1#referee-response-51772
NOTE: 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 13 Aug 2019
Reham Hassan, Faculty of Dentistry, Minia University, Minya, Egypt 
Approved
VIEWS 11
https://doi.org/10.5256/f1000research.21880.r51777
The current manuscript links between intra-canal medication, number of visits and the post-operative pain after endodontic treatment. While the results were insignificant, the antibiotic paste presents some disadvantages, like discoloration which was not reported.
 
Overall, the study was ... Continue reading
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HOW TO CITE THIS REPORT
Hassan R. Reviewer Report For: Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial [version 1; peer review: 1 approved, 2 approved with reservations]. F1000Research 2019, 8:1203 (https://doi.org/10.5256/f1000research.21880.r51777)
The direct URL for this report is:
https://f1000research.com/articles/8-1203/v1#referee-response-51777
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Report a concern
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Reviewer Report 12 Aug 2019
Alireza Adl, Department of Endodontics, Biomaterials Research Center, School of Dentistry, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran 
Approved with Reservations
VIEWS 10
https://doi.org/10.5256/f1000research.21880.r51774
This article is aimed at comparing the postoperative pain following single or two-visit endodontic treatment of necrotic teeth with apical periodontitis. The subject has been previously investigated when calcium hydroxide was used as the intracanal medicament. The point of this article ... Continue reading
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CITE
HOW TO CITE THIS REPORT
Adl A. Reviewer Report For: Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial [version 1; peer review: 1 approved, 2 approved with reservations]. F1000Research 2019, 8:1203 (https://doi.org/10.5256/f1000research.21880.r51774)
The direct URL for this report is:
https://f1000research.com/articles/8-1203/v1#referee-response-51774
NOTE: 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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Open Peer Review

Reviewer Status

Alongside their report, reviewers assign a status to the article:

Approved
The paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved
Fundamental flaws in the paper seriously undermine the findings and conclusions

Reviewer Reports

Invited Reviewers
1 2 3
Version 1
26 Jul 19 		read read read
  1. Alireza Adl, Shiraz University of Medical Sciences (SUMS), Shiraz, Iran
  2. Reham Hassan, Minia University, Minya, Egypt
  3. A. R. Vivekananda Pai, Melaka-Manipal Medical College (Manipal Academy of Higher Education [MAHE]), Malacca City, Malaysia
    Htoo Htoo Kyaw Soe, Melaka-Manipal Medical College (Manipal Academy of Higher Education [MAHE]), Malacca City, Malaysia

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    Alongside their report, reviewers assign a status to the article:
    Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
    Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
    Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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