Pulpotomy versus partial pulpectomy for deep cavities in primary molars
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial
This trial tests whether pulpotomy or partial pulpectomy better treats vital primary molars with deep cavities and irreversible pulpitis in children aged 4 to 6.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06293521 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares clinical and radiographic success rates of pulpotomy (using calcium silicate–based materials) versus partial pulpectomy for vital primary molars with deep caries and signs of irreversible pulpitis. Children aged 4–6 in good general health with restorable, exposed primary molars and prolonged bleeding after coronal pulp removal will be enrolled and treated at Cairo University. Participants will receive one of the two procedures and be followed with clinical exams and dental radiographs at scheduled visits to monitor pain, infection signs, and radiographic healing. Teeth with preoperative radiographic pathology, swelling, or pathological mobility are excluded and outcomes will be compared to determine which approach best preserves tooth function and structure.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 4–6 with restorable vital primary molars showing deep caries, pulp exposure, and continued bleeding after coronal pulp removal.
Not a fit: Children with swelling, pathological mobility, preoperative radiographic pathology (resorption or periradicular/furcation radiolucency), previously accessed teeth, or those unable to attend follow-up visits are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the less invasive pulpotomy approach could preserve more primary teeth with fewer procedures and complications than pulpectomy.
How similar studies have performed: While calcium silicate–based pulpotomy techniques have shown success in mature permanent teeth and some emerging pediatric reports, high-quality evidence specifically in primary teeth with irreversible pulpitis remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 4 to 6 years , in good general health 2. The parents provided written informed consent. 3. Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue. 4. Restorable teeth. Exclusion Criteria: 1. Physical or mental disability. 2. Unable to attend follow-up visits. 3. Previously accessed teeth. 4. Swelling, tenderness to percussion or palpation, or pathological mobility. 5. Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Nada Mostafa, B.D.S
- Email: Nadamostafa@dentistry.cu.edu.eg
- Phone: 01117311533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.