Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis
Status:
RECRUITING
Trial end date:
2025-08-07
Target enrollment:
Participant gender:
Summary
This study, approved by the Institutional Ethics Review Committee, AFID (Annex "A"), will involve 62 eligible patients from the Operative Dentistry Department, Armed Forces Institute of Dentistry. Patients (and their guardians) will receive a detailed explanation in Urdu, and written informed consent will be obtained (Annex "B").
Study Design:
Randomized Controlled Trial: Patients will be randomly divided into two equal groups using a scientific random number table.
Inclusion Screening: Includes medical history, clinical examination, periapical radiographs.
Treatment Protocol:
Root canal therapy under local anesthesia with rubber dam isolation.
Working length determined using DentaPort ZX apex locator, confirmed with radiograph.
Instrumentation: ProTaper Universal hand files up to F2 with 5.25% NaOCl irrigation.
Patency confirmed with #10 K-file between each instrument change.
Final flush with 17% EDTA.
Calcium hydroxide used as intracanal medicament for microbial control.
Temporary restoration using Cavit.
Recall and Evaluation: After 1 week, asymptomatic patients (VAS score 0 and dry canals) will be selected for obturation.
Obturating Materials:
Group 1: AD Seal + F2 single cone gutta-percha (Sure Endo). Group 2: Pulp-dent Sealer + F2 single cone gutta-percha (Sure Endo). Sealers will be mixed per manufacturer's instructions, applied using lentulospiral. The apical extent of the master cone will be confirmed radiographically.
All procedures will be carried out by a single operator. Final restoration will be done using composite, and patients will be referred for full coverage crowns.
Post-Treatment Pain Assessment:Patients will receive a pain diary with a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (severe pain).
Pain will be recorded at 24 hours, 72 hours, and 7 days post-treatment. Analgesic use (type and quantity) will also be noted. Diaries will be collected at the follow-up visit.