NCT07266974

Brief Summary

The goal of this randomized clinical trial is to evaluate pain after root canal treatment using two different kinds of sealers during obturation in 60 healthy , male and female patients ages between 18 to 40 years. The main aims is to systematically evaluate and compare post-operative pain levels in patients undergoing root canal treatment with two different types of endodontic sealers: AH plus (SEAL APEX) and bio ceramic sealer(META) • By identifying the sealer that leads to the least discomfort, this research could significantly enhance patient care, minimize recovery time, and improve overall treatment success in endodontics. Participants in both groups will be given a visual analogue scale(VAS) to measure the pain level after the root canal treatment has been completed. They will measure pain levels at 12, 24 and 48 hours. All information will be recorded on proforma and compared.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
5mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

November 24, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

post operative painbioceramic sealerirreversible pulpitis

Outcome Measures

Primary Outcomes (1)

  • post operative pain in both sealer groups after obturation

    Post-operative pain levels will be measured and compared in both groups using Visual Analogue Scale (VAS) Patients were asked to rate their pain on a numerical scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst pain imaginable. For interpretation, pain intensity was categorized as follows: 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain

    6 months

Study Arms (2)

Group A , AH plus sealer , Group B ( bioceramic sealer)

ACTIVE COMPARATOR

patients in group A will recieve AH plus sealer and in group B shall recieve bioceramic sealer for obturation during root canal treatment

Drug: bioceramic sealer

Group A , (AH plus sealer ) , Group B ( bioceramic sealer)

ACTIVE COMPARATOR

patients in Group A will recieve Ah plus sealer for obturation and patients in group B shall recieve bioceramic sealer for obtration during root canal treatment second visit

Drug: AH-Plus Epoxy Resin Sealer

Interventions

AH plus sealer is an epoxy resin based sealer that is biocompatible with good sealing ability

Group A , (AH plus sealer ) , Group B ( bioceramic sealer)

MTA based sealers,biocermic sealers are biocompatible, safe to use

Group A , AH plus sealer , Group B ( bioceramic sealer)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients ranging from 18 to 40 years.
  • Patients whose teeth have been diagnosed with Symptomatic irreversible pulpitis.
  • maxillary and mandibular teeth.
  • A normal periapical condition on radiograph, or one with little to no periodontal ligament (PDL) space widening, confirming the normal periapical state.
  • Teeth that can be restored.
  • Teeth with healthy periodontium.

You may not qualify if:

  • Non-restorable teeth.
  • Patients with poor health whose systemic complications could change the course of treatment.
  • Teeth with immature roots.
  • Teeth with periapical lesions or apical periodontitis.
  • Teeth with Necrotic pulp.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Margalla Institute of Health Sciences, Gulraiz phase III Quaid e azam Avenue, Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Dr lubna Pasha

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post Graduate Trainee

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations