RecruitingPhase 2NCT06975761

Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis

A COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN AFTER ROOT CANAL THERAPY USING TWO DIFFERENT ENDODONTIC SEALERS IN PATIENTS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS


Sponsor

Armed Forces Institute of Dentistry, Pakistan

Enrollment

62 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 40 Years

Inclusion Criteria4

  • Permanent mandibular first molar with irreversible pulpitis without swelling and sinus.
  • Patients of male gender between 20-40 years of age.
  • Systemically healthy patients with no other co morbidity classified as ASA-I
  • Patients who agree to attend for re call appointments and provide a written consent

Exclusion Criteria2

  • \- 1. Teeth with calcified canals and previously treated teeth. 2. Mandibular molars with reversible pulpitis. 3. Pregnant and lactating mothers. 4. Patients who are immunocompromised, anxious, mentally ill. 5. Cases of root fracture. 6. Patients who consumed analgesics 12-24 hrs before primary root canal therapy.
  • \. Patients who are allergic to any of the medications being tested.

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Interventions

DRUGResin Based sealer

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

DRUGZnO eugenol based sealers

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


Locations(1)

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, Pakistan

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NCT06975761