Outcome of Pulpotomy With MTA and Biodentin in Permanent... | NCT06913283

Studies
Outcome of Pulpotomy With MTA and Biodentin in Permanent Teeth With Caries Exposure

NCT06913283

Sponsor

Altamash Institute of Dental Medicine

Status

Not yet recruiting

Last Update Posted

Apr 24, 2025Actual

Enrollment

136Estimated

Phase

Not Applicable

Conditions

Pulpitis - Irreversible

Interventions

Pulp Therapy with Mineral trioxide aggregate (MTA)
Pulp Therapy with Biodentine

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2025Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Mar 30, 2025

First Submission Date that Met QC Criteria

Mar 30, 2025

First Posted Date

Apr 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2025

Last Update Posted Date

Apr 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ambreen Mengal, Dentist AMengal, Altamash Institute of Dental MedicinePrincipal Investigator

Lead Sponsor

Altamash Institute of Dental MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pulp Therapy with Mineral trioxide aggregate (MTA)	Procedure	MTA allowed to set for twenty four hours	Group A Mineral trioxide aggregate pulpotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants treated with MTA		6 months
Number of Participants treated with Biodentine		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mature permanent teeth

Exclusion Criteria:

Teeth with restorations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ambreen Mengal	Contact	+92 3337860653		ambreenmengal@hotmail.com
Dr. Zahid Iqbal	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altamash Institute of Dental Medicine		Karachi	Sindh	75500	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C086631	mineral trioxide aggregate
C506393	tricalcium silicate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided