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

Short Term Outcome of Complete Pulpotomy Using MTA vs Biodentine in Symptomatic Irreversible Pulpitis - A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Symptomatic Irreversible Pulpitis (SIP)
• Intervention / Treatment: Other: Biodentine pulpotomy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Khadija Zubair, Postgraduate trainee- FCPS; Phone Number: 03363605145; Email: khadija.zubair21@yahoo.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Dr Khadija Zubair
      • Contact: Dr Khadija Zubair, Postgraduate trainee- FCPS; Phone Number: 03363605145; Email: khadijazubair.2823578@duhs.edu.pk
      • Principal Investigator: Dr Khadija Zubair, Postgraduate Trainee- FCPS
      • Sub-Investigator: Dr Farah Naz, HOD of operative & endodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

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

1. Any traumatic injury
2. Non-restorable carious lesion
3. Immature or Open apices of roots
4. Internal or external Resorption
5. Calcified canals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTA; Pulpotomy material MTA	Other: Biodentine pulpotomy; Pulpotomy performed using Mineral Trioxide Aggregate (MTA)
Experimental: Biodentine; Pulpotomy material Biodentine	Other: Biodentine pulpotomy; Pulpotomy performed using Mineral Trioxide Aggregate (MTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Dr Khadija Zubair, Postgraduate Trainee- FCPS, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Complete pulpotomy; Symptomatic Irreversible Pulpitis
• Other Study ID Numbers: IRB-3724/DUHS/Approval/2024/92

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No