NCT06975761

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 29, 2025

Last Update Submit

May 8, 2025

Conditions

Post Operative Pain After Root Canal Therapy

Keywords

post operative painirreversible pulpitisendodontic sealers

Outcome Measures

Primary Outcomes (6)

  • Post-Operative pain by using resin based sealer on visual analogue scale

    endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.

    24 hours

  • Post-Operative pain by using resin based sealer on visual analogue scale

    endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale

    72 hours

  • Post-Operative pain by using resin based sealer on visual analogue scale

    endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale

    7 days

  • Post-Operative pain by using ZnO engenol based sealer on visual analogue scale

    endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.

    24 hours

  • Post-Operative pain by using ZnO engenol based sealer on visual analogue scale

    endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale

    72 hours

  • Post-Operative pain by using ZnO engenol based sealer on visual analogue scale

    endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale

    7 days

Study Arms (2)

Resin based sealer

ACTIVE COMPARATOR

Endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation)

Drug: Resin Based sealer

ZnO eugenol based sealer

ACTIVE COMPARATOR

Endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation)

Drug: ZnO eugenol based sealers

Interventions

Resin Based sealerDRUG

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

Resin based sealer
ZnO eugenol based sealersDRUG

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

ZnO eugenol based sealer

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Areeba Maryam, BDS

    AFID

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Areeba Maryam, BDS

CONTACT

+923344782776areebamaryam94@yahoo.com

Maha Ali Mirza, BDS

CONTACT

+923365605412mahaalimirza5@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident operative dentistry and endodontics

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 16, 2025

Study Start

April 7, 2025

Primary Completion

August 7, 2025

Study Completion

August 7, 2025

Last Updated

May 16, 2025

Record last verified: 2025-04

Locations

PA(1)