Short Term Comparative Assessment of MTA and Biodentine i... | NCT07483788

Studies
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis

NCT07483788

Sponsor

Dow University of Health Sciences

Status

Recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Interventions

Biodentine pulpotomy

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

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2024Actual

Primary Completion Date

Apr 30, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Nov 28, 2025

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 19, 2026Actual

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

Mar 16, 2026

Last Update Posted Date

Mar 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Khadija Zubair, Postgraduate Trainee FCPS, Dow University of Health SciencesPrincipal Investigator

Lead Sponsor

Dow University of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

All Patients coming to the Operative Dentistry Department (DIDC-DUHS) with complain of pain in posterior teeth will be invited to participate. The treatment will be done by one dentist. Patient's medical and dental history will be recorded, and tooth will be checked for swelling, sensitivity, cavity type, and loosening of tooth. Special tests like the cold test, electric pulp test, and an X-ray will help assess the tooth's condition. Patient will also be asked to rate pain from 1-10. Before starting the treatment, the procedure will be explained to patient in detail, and written consent will be taken. The treatment will be done in two visits by one dentist. Patient will be given an injection to make tooth pain-free so that patient does not feel any discomfort during the treatment and the area will be kept clean using a rubber sheet. The dentist will remove the hole in tooth and remove the infected soft part of tooth and stop the bleeding. Then one of the two materials will be placed inside the tooth. A temporary filling will be placed first, and patient will come the next day for the final filling. An X-ray will be taken to check the result. If patient feel pain, may take ibuprofen (400 mg) as needed, and if the pain continues, please contact the dentist. Patient will be called for follow-ups after 1 day, 1 week, 1 month, and 3 months to make sure the tooth is healing properly.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MTA	Experimental	Pulpotomy material MTA	Other: Biodentine pulpotomy
Biodentine	Experimental	Pulpotomy material Biodentine	Other: Biodentine pulpotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biodentine pulpotomy	Other	Pulpotomy performed using Mineral Trioxide Aggregate (MTA)	Biodentine MTA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Short term outcome of complete pulpotomy using MTA vs Biodentine in Symptomatic Irreversible Pulpitis- A Randomized Controlled Trial	Clinical outcome measure through Electric pulp testing (EPT) and radiographic outcome measure through Periapical index (PAI)	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Teeth of generally healthy patients having following criteria will be included:

Age between 18-40 years of both males and females
Carious exposed maxillary and mandibular molars teeth
Moderate to severe pain (VAS 4-10)
Diagnosed with Symptomatic irreversible pulpitis on cold test and Electric pulp test (EPT)
Periapical index of 1
Hemostasis is achieved within 10 mins after full pulpotomy

Exclusion Criteria:

Teeth of generally healthy patients having following criteria will be excluded:

Any traumatic injury
Non-restorable carious lesion
Immature or Open apices of roots
Internal or external Resorption
Calcified canals

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
Dr Khadija Zubair, Postgraduate trainee- FCPS	Contact	03363605145		khadija.zubair21@yahoo.com

Overall Officials

Name	Affiliation	Role
Dr Khadija Zubair, Postgraduate Trainee- FCPS	Dow University of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr Khadija Zubair	Recruiting	Karachi	Sindh		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared outside the study team to ensure patient confidentiality and privacy. Data will be used only for the purposes of this study and will remain restricted to the research team

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided