Comparing MTA versus Biodentine for complete pulpotomy in painful molars

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

This will test whether MTA or Biodentine works better to relieve pain and preserve the tooth in adults (18–40) with symptomatic irreversible pulpitis in a molar.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Dow University of Health Sciences (other)
• Locations: 2 sites (Karachi, Sindh and 1 other locations)
• Trial ID: NCT07483788 on ClinicalTrials.gov

What this trial studies

Adults aged 18–40 who present with moderate to severe pain from cariously exposed maxillary or mandibular molars and meet diagnostic tests for symptomatic irreversible pulpitis will be treated at Dow University of Health Sciences. Treatment is done by one dentist over two visits with local anesthesia and rubber-dam isolation; the coronal pulp is removed, bleeding controlled within 10 minutes, and then either MTA or Biodentine is placed. Pain will be recorded on a 1–10 scale and baseline tests include cold test, electric pulp testing, and a periapical radiograph; follow-up focuses on short-term clinical outcomes. The trial compares the two biomaterials' performance for complete pulpotomy in this specific patient group at a single center in Karachi.

Who should consider this trial

Good fit: Adults 18–40 with cariously exposed molars, moderate-to-severe pain (VAS 4–10), positive cold/EPT indicating symptomatic irreversible pulpitis, a periapical index of 1, and where hemostasis can be achieved within 10 minutes are ideal candidates.

Not a fit: Patients with traumatic injuries, non-restorable lesions, immature/open root apices, internal or external resorption, calcified canals, or those who cannot achieve hemostasis within 10 minutes are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the finding could offer a reliable, less invasive option to quickly relieve pain while preserving the tooth's vitality.

How similar studies have performed: Previous clinical reports have shown promising short-term success using MTA for pulpotomy and emerging evidence suggests Biodentine often achieves similar outcomes, though follow-up durations vary.

Eligibility criteria

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

Where this trial is running

Karachi, Sindh and 1 other locations

• Dr Khadija Zubair — Karachi, Sindh, Pakistan (RECRUITING)
• Dr Khadija Zubair — Karachi, Sindh, Pakistan (RECRUITING)

Study contacts

• Principal investigator: Dr Khadija Zubair, Postgraduate Trainee- FCPS — Dow University of Health Sciences
• Study coordinator: Dr Khadija Zubair, Postgraduate trainee- FCPS

Conditions: Symptomatic Irreversible Pulpitis, Complete pulpotomy