Effect of Intracanal Medicaments on Post-Operative Pain in Symptomatic Apical Periodontitis: An RCT

HITEC-Institute of Medical Sciences

Status: Completed

Conditions: Periodontal Diseases

Treatments: Drug: Modified Triple Antibiotic Paste; Drug: Chlorhexidine Gel (2%); Drug: Calcium Hydroxide (20%)

Study type: Interventional

Funder types: Other

Identifiers

NCT07123792

Dr Fatimah

Details and patient eligibility

About

Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis

Full 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.

Enrollment: 480 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single rooted teeth (Anterior or posterior)
• Teeth with acute symptomatic apical periodontitis

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 3 patient groups

Calcium Hydroxide group

Experimental group

Description:

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.

Treatment:

Drug: Calcium Hydroxide (20%)

Chlorhexidine group

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine Gel (2%)

Modified triple antibiotic paste

Experimental group

Description:

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.

Treatment:

Drug: Modified Triple Antibiotic Paste