Actively Recruiting

Phase 2
Age: 20Years - 40Years
All Genders
Healthy Volunteers
NCT06975761

Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis

Led by Armed Forces Institute of Dentistry, Pakistan · Updated on 2025-05-16

62

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis

Who Can Participate

Age: 20Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Permanent mandibular first molar with irreversible pulpitis without swelling and sinus
  • Male patients aged 20 to 40 years
  • Systemically healthy patients with no other comorbidities classified as ASA-I
  • Patients willing to attend follow-up visits and provide written consent
Not Eligible

You will not qualify if you...

  • Teeth with calcified canals or previously treated teeth
  • Mandibular molars with reversible pulpitis
  • Pregnant or lactating women
  • Patients who are immunocompromised, anxious, or mentally ill
  • Cases with root fracture
  • Patients who took analgesics 12-24 hours before root canal therapy
  • Patients allergic to any medications being tested

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, Pakistan, 46000

Actively Recruiting

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Research Team

A

Areeba Maryam, BDS

CONTACT

M

Maha Ali Mirza, BDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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