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Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis

NCT06975761 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

  • Post Operative Pain After Root Canal Therapy

Interventions

DRUG

Resin Based sealer

Post-operative pain after Root Canal Therapy by using resin based sealer

DRUG

ZnO eugenol based sealers

Post-operative pain after Root Canal Therapy by using ZnO eugenol based sealer

Sponsors & Collaborators

  • Armed Forces Institute of Dentistry, Pakistan

    lead OTHER

Principal Investigators

  • Areeba Maryam, BDS · AFID

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2025-08-07
Completion
2025-08-07
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975761 on ClinicalTrials.gov