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

NCT07253025 | Recruiting DMC

• 1 other identifier: Prime Foundation Pakistan
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Change in the baseline of pain, as measure by the visual analog scale ( VAS)

  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

Study Arms (2)

POST OPERATIVE PAIN IN RESIN-BASED ROOT CANAL SEALERS

OTHER

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

POST OPERATIVE PAIN BIOCERAMIC BASED ROOT CANAL SEALERS

OTHER

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

Interventions

Resin based root canal sealer OTHER

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.

POST OPERATIVE PAIN IN RESIN-BASED ROOT CANAL SEALERS

Bioceramic based root canal sealer OTHER

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

POST OPERATIVE PAIN BIOCERAMIC BASED ROOT CANAL SEALERS

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prime Foundation: lead

Study Sites (1)

Peshawar Dental Collge

Peshawar, Khyber Pakhtoon Khawa(KPK)a, 25000, Pakistan

RECRUITING

Related Links

• Parent study Reference

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dr. Shah Zaman, BDS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shah Zaman, BDS

CONTACT

0092 3159393980; zshah5778@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docter

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 28, 2025
• Study Start: November 30, 2025
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Material will be available 6 months after publication of primary outcomes
• Access Criteria: Investigators having studying similar primary outcomes

Locations

PA (1)