Completed

Biodentine for Symptomatic Irreversible Pulpitis in Mature Permanent Teeth

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What is being tested

Complete Pulpotomy with Biodentine

Procedure
Who is being recruted

From 20 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorHITEC-Institute of Medical Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 2, 2024

Actual date on which the first participant was enrolled.

This study focuses on assessing the effectiveness of a dental procedure called complete pulpotomy using a material known as Biodentine. It specifically targets mature permanent single-rooted teeth that have a condition termed symptomatic irreversible pulpitis, where the dental pulp is inflamed and cannot heal on its own. The importance of this study lies in finding a reliable method to treat this condition, potentially offering a less invasive alternative to root canal treatment. Biodentine is chosen for its ability to support the healing of the remaining pulp and its antibacterial properties, contributing to better dental health outcomes. Participants in this study will undergo a complete pulpotomy, where the top part of the tooth's pulp is removed while the lower part is preserved using Biodentine. This dental material acts as a protective layer and encourages healing. The study will monitor patients over a period of time to determine the success of the treatment by checking for the absence of symptoms like pain and swelling, and ensuring there are no signs of infection or complications on X-rays. Evaluations will occur at different intervals, specifically at 7 days, 1 month, and 3 months after the procedure, to ensure comprehensive assessment of the treatment's effectiveness.

Official TitleEvaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis
NCT07112859
Principal SponsorHITEC-Institute of Medical Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Mature permanent single rooted teeth with: * Symptomatic irreversible pulpitis * Age group 20-50 years Exclusion Criteria: * • Uncontrolled pulp heamorrhage (more than 5mins) * Necrotic pulp * Periapical periodontitis * Sinus tract * Abnormal tooth mobility * Single rooted teeth with internal or external root resorption * Calcified root canals

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients with mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis will undergo complete pulpotomy. The coronal pulp will be removed, and Biodentine will be placed on the remaining radicular pulp, followed by restoration. Patients will be followed up to evaluate treatment success.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Dental hospial, Hitec-IMS

Rawalpindi, PakistanOpen Dental hospial, Hitec-IMS in Google Maps
CompletedOne Study Center
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