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Recruiting NCT07483788

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

No phase Interventional Symptomatic Irreversible Pulpitis (SIP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biodentine pulpotomy.
Who it may be relevant to
Registry conditions: Symptomatic Irreversible Pulpitis (SIP). Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Biodentine pulpotomy
    Pulpotomy performed using Mineral Trioxide Aggregate (MTA)

Primary outcome measures

  • Short term outcome of complete pulpotomy using MTA vs Biodentine in Symptomatic Irreversible Pulpitis- A Randomized Controlled Trial [Time frame: 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 2 centers
  • Dr Khadija Zubair — Karachi
  • Dr Khadija Zubair — Karachi

Identifiers

NCT: NCT07483788 · IRB-3724/DUHS/Approval/2024/92

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗