Comparison of Post Operative Pain in Resin-Based and Bioceramic Based Root Canal Sealers in Patient Presenting at Peshawar Dental College.

November 24, 2025 updated by: Shah Zaman, Prime Foundation

Comparison of Post Operative Pain in Resin-Based and Bio Ceramic Based Root Canal Sealer in Patient Presenting at Peshawar Dental College

The goal of this clinical trial is to compare the post operative pain in Resin-Based and Bio ceramic based sealers in patients presenting at Peshawar dental college.

Root canal sealer is a material use to avoid gaps between the filling material and root canal Walls, if it is extended beyond canals can cause mild inflammation and post operative pain Hypothesis: There is difference in post operative pain in Resin based and Bio ceramic based sealers in patients presenting at Peshawar dental college.

.Post operative pain:: It will be defined on the basis of Visual Analog Score (VAS) after 24 hours and 48hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates the severe pain. Presence of pain will be validated, if Pain > 3 on VAS.

•The calculated sample size is 180 (90 in each group) Patients will be briefed with information related to the goals, risks, and benefits of the study, and written informed consent form will be taken from all participating patients. To make sure the inclusion criteria are strictly enforced, medical history will be taken. Demographic information like to age, gender, and address will be recorded on a designated proforma. Maxillary or mandibular single-rooted teeth confirmed with symptomatic irreversible pulpitis i.e. normal apical tissues/symptomatic apical periodontitis will be included. Patients will be randomly divided into two groups Resin-based sealer (AH Plus)-Group A (90) and mineral trioxide aggregate (MTA) fillapex-Group B (90) by lottery method. Before treatment the patients will be educated that how to complete a visual analogue scale (VAS) to evaluate their pain score. The VAS included a 10 cm straight horizontal line numbered at each centimetre with the following criteria. Local anaesthetic with 2% lignocaine containing 1:80000 epinephrine will be administered to each patient. A rubber dam will be applied. The endodontic access cavities will be formed with endo access burs. Working length will be established with #10 K file and the root canal will be instrumented with one shape rotary system up to #25.6% under copious irrigation with 3% sodium hypochlorite. Before obturation root canals will be final rinse with 5 ml of 17% EDTA solution. In both treatment groups, the root canal will be dried with paper points and obdurate with cold lateral compaction technique with the help of gutta-percha cones and AH plus /MTA fillapex. Coronal access cavities will be restored with direct composite restorations with the help of dentinal adhesives and universal composite resin. The continuous-wave approach will be used in the AH Plus group, and the single-cone approach will be used in the MTA fillapex. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Khyber Pakhtoon Khawa(KPK)a
      • Peshawar, Khyber Pakhtoon Khawa(KPK)a, Pakistan, 25000
        • Recruiting
        • Peshawar Dental Collge
        • Contact:
        • Sub-Investigator:
          • Dr. Iftikhar Akbar, BDS, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gender Both males and females
  • Age Group (18-70) Years
  • Patients with Mandibular or Maxillary single-rooted teeth identified with symptomatic irreversible pulpitis either with symptomatic apical periodontitis or normal apical tissues

Exclusion Criteria:

  • Patients with immature apices
  • Patients with root resorption
  • Patients medically compromised, Patients on medications i.e analgesic or anti-inflammatory drugs,
  • pregnant/lactating females
  • Patient came with flare up pain
  • Patients who refused to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: POST OPERATIVE PAIN IN RESIN-BASED ROOT CANAL SEALERS
Patients will be randomly divided into two groups .one group will recived Resin-based sealer (AH Plus)-Group A (90) . Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score.
Other: Resin based root canal sealer

Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.

The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria It will be defined on the basis of Visual Analog Score (VAS) after 24 hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates the severe pain. Presence of pain will be validated, if Pain > 3 on VAS.
Other: POST OPERATIVE PAIN BIOCERAMIC BASED ROOT CANAL SEALERS
Patients will be randomly divided into two groups. Mineral trioxide aggregate (MTA) fillapex-Group B (90). Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score.
Other: Bioceramic based root canal sealer

Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.

The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria It will be defined on the basis of Visual Analog Score (VAS) after 24 hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the baseline of pain, as measure by the visual analog scale ( VAS)
Time Frame: 24 hours , 48 hours
Scores are measure on 10 numbers on VAS , where 0 Indicate no pain and 10 Indicate severe pain , presence of pain will be validated, if pain score >3 on VAS scale,
24 hours , 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prime Foundation

Investigators

  • Principal Investigator: Dr. Shah Zaman, BDS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

April 2, 2026

Study Completion (Estimated)

April 2, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prime Foundation Pakistan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, inform consent, study results

IPD Sharing Time Frame

Material will be available 6 months after publication of primary outcomes

IPD Sharing Access Criteria

Investigators having studying similar primary outcomes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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