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RecruitingNCT07483788Updated Mar 19, 2026

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

An interventional study of Biodentine pulpotomy in Symptomatic Irreversible Pulpitis (SIP), sponsored by Dow University of Health Sciences. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
  • Registered 1 year after the study started (first participant enrolled Nov 2024, registered Nov 2025).
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Symptomatic Irreversible Pulpitis (SIP)

Keywords

  • Symptomatic Irreversible Pulpitis
  • Complete pulpotomy
03

In context

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 171 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    MTA

    Pulpotomy material MTA

    Other: Biodentine pulpotomy

  • Experimental
    Biodentine

    Pulpotomy material Biodentine

    Other: Biodentine pulpotomy

Interventions

  • OtherBiodentine pulpotomy

    Pulpotomy performed using Mineral Trioxide Aggregate (MTA)

06

What researchers measure

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)

    Time frame: 3 months

07

Study locations

2 of 2 sites recruiting
  • Dr Khadija Zubair
    Karachi, Sindh, Pakistan
    • Dr Khadija Zubair, Postgraduate trainee- FCPS · Contact · khadijazubair.2823578@duhs.edu.pk · 03363605145
    • Dr Khadija Zubair, Postgraduate Trainee- FCPS · Principal investigator
    • Dr Farah Naz, HOD of operative & endodontics · Sub investigator
    Recruiting
  • Dr Khadija Zubair
    Karachi, Sindh, Pakistan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07483788
Lead sponsor
Dow University of Health Sciences
Responsible party
Dr. Khadija Zubair (Postgraduate Trainee FCPS, Dow University of Health Sciences) — Principal investigator
First posted
Mar 19, 2026
Start date
Nov 2, 2024
Primary completion
Apr 30, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Mar 19, 2026

Study contacts

Dr Khadija Zubair, Postgraduate trainee- FCPS
Contact
khadija.zubair21@yahoo.com
03363605145
Dr Khadija Zubair, Postgraduate Trainee- FCPS
principal investigator · Dow University of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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