To Evaluate Post Operative Pain Using Two Different Kind of Sealers in Obturation of Teeth With Symptomatic Irreversible Pulpitis During Second Visit When the Patient is Painless
Evaluation of Post -Operative Pain After Obturation Using Two Different Types of Sealers - A Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2026
Shorter than P25 for phase_2
1 active site
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
First Submitted
Initial submission to the registry
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 8, 2026
January 1, 2026
5 months
November 24, 2025
January 6, 2026
Conditions
Keywords
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 COMPARATORpatients in group A will recieve AH plus sealer and in group B shall recieve bioceramic sealer for obturation during root canal treatment
Group A , (AH plus sealer ) , Group B ( bioceramic sealer)
ACTIVE COMPARATORpatients 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
Interventions
AH plus sealer is an epoxy resin based sealer that is biocompatible with good sealing ability
MTA based sealers,biocermic sealers are biocompatible, safe to use
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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