Comparison of Postoperative Pain After Double Antibiotic Paste vs Calcium Hydroxide in Teeth With Symptomatic Apical Periodontitis

Background:

Pain is a primary symptom of numerous medical and dental conditions that can greatly impact an individual's overall well-being. The frequency of pain following endodontic treatment varies widely across studies, with some reporting rates as low as 3% and others as high as 58%. The success and acceptance of endodontic treatment hinge greatly on its pain-free nature. Consequently, effective pain management stands as a pivotal element throughout endodontic procedures.

In endodontic treatment, the goal is to remove as many bacteria as possible from the root canal system and reduce the risk of reinfection. Chemo-mechanical preparation is crucial in eliminating bacteria, necrotic tissues, and infected dentin. However, various instrumentation systems result in an unpredictable range, leaving 2.6% to 80% of the root canal walls untouched. Therefore, instrumentation, irrigation, and obturation cannot reliably ensure the complete elimination of bacteria from the canals, and some residual bacteria may persist in untouched areas.

The effectiveness of endodontic treatment for teeth with apical periodontitis relies significantly on successfully eradicating or greatly reducing intracanal bacteria. To ensure the destruction of any remaining germs after chemical-mechanical preparation, antibacterial intracanal medicaments are recommended. Various intracanal medicaments are employed in dentistry for diverse purposes, including reducing residual bacteria after root canal instrumentation, minimizing postoperative inflammation, and effectively addressing pain.

The double antibiotic paste is a blend of metronidazole and ciprofloxacin employed as an intracanal antibiotic to disinfect necrotic teeth. Its effectiveness has been demonstrated in reducing bacterial counts within infected root canals. Abouelenien et al. conducted a study to evaluate postoperative pain after using calcium hydroxide versus double antibiotic paste. In group A (calcium hydroxide group), the median (range) postoperative pain at 24-hour follow-up was 1 (0-9). In group B (double antibiotic paste group), the median (range) postoperative pain at 24-hour follow-up was 0.5 (0-8).

Given the diversity in opinions and practices among dental professionals in Khyber Pakhtunkhwa (KPK), Pakistan, concerning intracanal medicaments for symptomatic apical periodontitis, a notable divide exists between those favoring double antibiotic paste (DAP) and those inclined towards calcium hydroxide. This disparity underscores the need for a comprehensive investigation into the comparative efficacy of these treatments, particularly concerning post-operative pain reduction-an issue of paramount concern for individuals undergoing dental procedures.

Objective:

To compare the mean postoperative pain after using double antibiotic paste versus calcium hydroxide in teeth with symptomatic apical periodontitis.

Hypothesis:

There is a difference between the mean postoperative pain after double antibiotic paste versus calcium hydroxide in teeth with symptomatic apical periodontitis.

Methods:

Study Design: Randomized Controlled Trial.

Study Setting: Operative \& Endodontic Department, Saidu College of Dentistry, Swat, Pakistan.

Duration of Study: Minimum of six months after the approval of synopsis from CPSP.

Sample Technique: Consecutive (non-probability) technique.

Sample Size: 662 patients (331 per group) calculated with OpenEpi at 95% confidence interval, 80% power of test using mean pain at 24 hours to be 2.099 ± 2.47 in calcium hydroxide group and 1.59 ± 2.19 in double antibiotic paste group from the previous study. The previous study did not report the values such as mean and SD required for sample size determination, so the available values (minimum, maximum, median, and sample size) were converted into mean and SD using a calculator based on the methodologies presented by Luo et al. (2018) and Wan et al. (2014).

Inclusion Criteria:

1. Patients with ages ranging from 16 to 50 years.
2. Teeth diagnosed with symptomatic apical periodontitis clinically by percussion and radiographically by the presence of radiolucency around the tooth apex.
3. Patients with good general health (no medical condition).

Exclusion Criteria:

1. Pregnant women.
2. Patients who had received antibiotic treatment during the last 3 months.
3. Patients having more than one tooth requiring root canal treatment.
4. Teeth with periodontal probing depth >4 mm measured with W.H.O probe.
5. Teeth that couldn't be isolated with a rubber dam.
6. Teeth with previous root canal treatment, or teeth with fluctuant facial swelling where emergency management should include incision and drainage.

Data Collection Procedures:

Approval of the hospital ethical review committee of Saidu College of Dentistry will be taken. Patients will be informed about the study's purpose, procedure, and benefits. An informed consent both oral and written will be taken for willingness and participation in this study. The patients will be assured regarding maintaining the confidentiality of their personal and other data collected from their records.

Before initiating endodontic treatment, 662 consecutive first-time patients aged 16 to 50 years who present at the Operative Dentistry Department of Saidu College of Dentistry will complete a questionnaire-based history and undergo a clinical examination, radiographic examination, and diagnostic test (clinical symptoms involving a painful response to biting and/or percussion or palpation and radiographically by widening of periodontal ligament space) to evaluate the symptomatic apical periodontitis, and will be documented in proforma.

Participants will be randomly divided into two groups by lottery method. Group A will receive calcium hydroxide and Group B will receive double antibiotic paste. Each patient will mark the pain on a Visual Analog Scale (VAS) questionnaire as numeric value. All this data will be recorded in proforma following inclusion and exclusion criteria.

After local anesthetic (HD CAINE plus inj- 2% lidocaine hydrochloride with adrenaline 1:100,000) has been applied, the tooth that needs treatment will be isolated using a rubber dam. Using a high-speed handpiece, an access cavity will be made where the carious lesion is (this process is known as access opening). After locating the root canal orifices, the pulpectomy operation will be performed using manual hand K files (Mani-K Files). As decided by radiography and tactile perception, the working length will now be measured just 1 mm short of the apex. During this appointment, the chemo-mechanical preparation will also be completed. The Step Back technique will be used to clean and shape the canals after the working length has been determined. To eliminate all the debris, irrigation with 3% sodium hypochlorite (Tehno Dent - Antiseptic Liquid - Sodium Hypochlorite) will be done occasionally. To avoid the formation of a smear layer, 17% EDTA (PD - EDTA 17% Gel) will be used. After one minute, the canal will be cleaned with ordinary saline solution. Before inserting intracanal drugs, the canals will be dried with absorbent paper points (Meta BioMed). The access cavity will now be filled with temporary restorative material that contains cotton pellets, and the root canals will now be filled with intracanal medicament. After 1 hour and at 24 hours following therapy, the patient will be questioned about their level of pain on cell phones.

Statistical Analysis:

Statistical analysis will be done in SPSS 24. Mean and standard deviation will be calculated for age and pain score (VAS score) numeric data. Frequency and percentages will be completed for categorical data like gender. Pain score will be compared between two groups using student t-test or Mann-Whitney U test (if skewed assessed by Shapiro-Wilk test). Stratification will be done with respect to gender and age group to see effect modifiers. Post-stratification student t-test or Mann-Whitney U test (if skewed assessed by Shapiro-Wilk test) will be performed for pain type and a score P ≤ 0.05 will be significant.

Outcome Measures:

Primary Outcome: Mean postoperative pain measured on a 10-point Visual Analog Scale (VAS) at 24 hours after treatment.

Secondary Outcome: Mean postoperative pain measured on a 10-point Visual Analog Scale (VAS) at 1 hour after treatment.