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

NCT07483788 | Recruiting DMC

• 1 other identifier: IRB-3724/DUHS/Approval/2024/92
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Keywords

Symptomatic Irreversible Pulpitis; Complete pulpotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MTA

EXPERIMENTAL

Pulpotomy material MTA

Other: Biodentine pulpotomy

Biodentine

EXPERIMENTAL

Pulpotomy material Biodentine

Other: Biodentine pulpotomy

Interventions

Biodentine pulpotomy OTHER

Pulpotomy performed using Mineral Trioxide Aggregate (MTA)

Biodentine; MTA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (2)

Dr Khadija Zubair

Karachi, Sindh, Pakistan

RECRUITING

Dr Khadija Zubair

Karachi, Sindh, Pakistan

RECRUITING

Study Officials

• Dr Khadija Zubair, Postgraduate Trainee- FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Khadija Zubair, Postgraduate trainee- FCPS

CONTACT

03363605145; khadija.zubair21@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Trainee FCPS

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: March 19, 2026
• Study Start: November 2, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)