Pulpotomy vs Pulpectomy for painful baby teeth in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a parallel, open-label randomized trial comparing pulpotomy to pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis. About 80 teeth in cooperative children will be randomized 1:1 to receive either pulpotomy or pulpectomy and followed over two years. The trial aims to determine non-inferiority of pulpotomy relative to pulpectomy using standard restorative and follow-up procedures. Eligibility requires healthy, cooperative children with a vital pulpal diagnosis and teeth suitable for stainless steel crowns. Outcomes focus on clinical and radiographic success, tooth retention, and patient tolerance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
3. The pulp of the affected primary molar is vital.
4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
5. The affected primary molars can be restored with full coverage stainless steel crowns.
6. Any physiologic root resorption, if present, is less than ⅓ the root length.

Exclusion Criteria:

1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).
2. Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.
3. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
4. Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.
5. Parents not willing to place full coverage crowns post-treatment.
6. Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.
7. Unable to perform clinical procedure under rubber dam

Where it's running

• Jordan University of Science and Technology
  Irbid, Jordan Recruiting
• Primary Health Care Corporation
  Doha, Qatar Active not recruiting

Study contacts

• Principal investigator: Nebu Philip, MDS, PhD — Qatar University
• Study coordinator: Nebu Philip, MDS, PhD
• Email: nphilip@qu.edu.qa
• Phone: +974-44037319

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Single Rotary File System vs Manual Instrumentation for Pulpectomy in Primary Molars

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• Complete pulpotomy versus root canal for irreversible pulpitis in adults with Type 2 diabetes

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• Evaluating the effectiveness of pulpotomy for treating deep caries in permanent teeth

  This study is testing how well pulpotomy treatments work for adults with deep tooth decay to see if they can keep their teeth healthy and pain-free.

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• Evaluating the success of vital pulp therapy methods for dental pulp exposure

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• Measuring bite force to understand dental pain

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  Recruiting Rutgers, The State University of New Jersey · Newark, New Jersey · NCT06843525

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.