Effect of Intracanal Medicaments on Post-Operative Pain in Symptomatic Apical Periodontitis: An RCT
- Conditions
- Periodontal Diseases
- Interventions
- Registration Number
- NCT07123792
- Lead Sponsor
- HITEC-Institute of Medical Sciences
- Brief Summary
Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis
- Detailed Description
Pain is the most common clinical symptom associated with endodontic treatment. Symptomatic apical periodontitis (SAP) results in significant post-operative discomfort due to microbial invasion and inflammatory changes in periapical tissues. Intracanal medicaments are used to reduce microbial load and inflammation between treatment appointments, potentially reducing post-treatment pain. This study investigates the comparative effectiveness of three commonly used intracanal medicaments in reducing pain following biomechanical preparation:
Group 1: Calcium hydroxide (CH)
Group 2: Chlorhexidine gel (CHX 2%)
Group 3: Modified Triple Antibiotic Paste (TAP) - a combination of ciprofloxacin, clindamycin, and metronidazole in 1:1:1 ratio
A total of 480 participants with single-rooted teeth diagnosed with symptomatic apical periodontitis will be randomly assigned into three groups (160 in each group). Endodontic treatment will be performed by a single operator under standard protocols. No systemic analgesics or antibiotics will be prescribed. Pain assessment will be done using the Wong-Baker FACES Pain Rating Scale (0-10), and recorded at baseline (0 h), 6 h, 24 h, and 48 h after treatment.
The study aims to provide evidence on the most effective intracanal medicament to minimize post-operative pain, improving patient outcomes and guiding clinical decision-making.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- Single rooted teeth (Anterior or posterior)
- Teeth with acute symptomatic apical periodontitis
- Non-restorable teeth, presence of endo-perio lesions, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
- Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
- Patients with parafunctional habits
- Patients who were allergic to medications that were used in the study
- Patients who were taking medicines that could influence pain perception
- Patients that had any serious medical illness or with systemic disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium Hydroxide group Calcium Hydroxide (20%) Participants in this group will receive 20% calcium hydroxide paste as the intracanal medicament after root canal instrumentation. The medicament will be placed using a Lentulo spiral, excess removed from the chamber, and the tooth sealed with glass ionomer cement. Pain will be assessed at 0, 6, 24, and 48 hours postoperatively. Chlorhexidine group Chlorhexidine Gel (2%) Participants in this group will receive 2% chlorhexidine gel as the intracanal medicament following canal preparation. It will be placed with a Lentulo spiral and sealed in the same manner. Postoperative pain will be evaluated at the same intervals. Modified triple antibiotic paste Modified Triple Antibiotic Paste Participants in this group will receive a modified triple antibiotic paste made from ciprofloxacin, metronidazole, and clindamycin in a 1:1:1 ratio by weight. The paste will be placed inside the canal using a Lentulo spiral and sealed as per protocol. Pain will be recorded at 0, 6, 24, and 48 hours post-treatment.
- Primary Outcome Measures
Name Time Method Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS) At baseline (0 hours), 6 hours, 24 hours, and 48 hours post-operatively Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale (WFPRS), a validated 6-point facial expression scale. The scale ranges from 0 (no pain) to 10 (worst pain), with corresponding facial images used to help patients subjectively rate their pain. This tool will be used during follow-up calls to determine the patient's level of pain after root canal instrumentation and medicament placement.
Units of Measurement:
Score range: 0-10 (intervals of 2)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dental hospial, Hitec-IMS
🇵🇰Rawalpindi, Punjab, Pakistan
Dental hospial, Hitec-IMS🇵🇰Rawalpindi, Punjab, Pakistan