NCT06913283

Brief Summary

The success of pulpotomy treatment is affected by the type of biologically active material used.The effects of MTA and biodentine are compared in mature permanent teeth with caries exposure.It is expected that pulpotomy using biodentine will have a high success rate in caries exposed mature teeth compared to mineral trioxide aggregate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

March 30, 2025

Last Update Submit

April 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of participants treated with MTA

    6 months

  • Number of Participants treated with Biodentine

    6 months

Study Arms (2)

Group A Mineral trioxide aggregate pulpotomy

ACTIVE COMPARATOR
Procedure: Pulp Therapy with Mineral trioxide aggregate (MTA)

Group B Biodentine pulpotomy

ACTIVE COMPARATOR
Procedure: Pulp Therapy with Biodentine

Interventions

MTA allowed to set for twenty four hours

Group A Mineral trioxide aggregate pulpotomy

Biodentine is triturated before use

Group B Biodentine pulpotomy

Eligibility Criteria

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

You may qualify if:

  • mature permanent teeth

You may not qualify if:

  • Teeth with restorations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Interventions

mineral trioxide aggregatetricalcium silicate

Central Study Contacts

Dr. Zahid Iqbal

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist AMengal

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 6, 2025

Study Start

May 2, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

IPD will not be shared because it is mentioned in the patient consent form that details given by the patient and their identity will be kept confidential.

Locations