Bioceramic putty versus MTA for pulpotomy of second primary molars with 3D-printed resin or stainless steel crowns
Effectiveness of Bioceramic Calcium Silicate-based Pulpotomy Medicament on Primary Molars Restored With 3d Printed Resin Crowns (a Randomized Controlled Clinical Trial)
This trial will test whether bioceramic putty or MTA works better for pulpotomy in healthy, cooperative children aged 5–7 with deep carious second primary molars that will be covered with either 3D-printed resin crowns or stainless steel crowns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 7 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07344038 on ClinicalTrials.gov |
What this trial studies
Children aged 5–7 with deep carious second primary molars that reach the pulp will have caries removed and pulpotomy performed after achieving hemostasis. The exposed pulp chamber will be covered with either MTA or EndoSequence bioceramic putty, then a resin-modified glass ionomer will be placed and the tooth prepared for full coverage. Teeth will receive either conventional stainless steel crowns or 3D-printed resin crowns as the final restoration. Clinical and radiographic outcomes will be monitored during follow-up visits to compare success between the materials and crown types.
Who should consider this trial
Good fit: Healthy, cooperative children aged 5–7 with vital, deeply carious second primary molars requiring pulpotomy and full-coverage restoration are ideal candidates.
Not a fit: Children with spontaneous pain, tooth mobility, excessive bleeding after pulp amputation, radiographic signs of root resorption or periapical pathology, prior treatment of the tooth, or special healthcare needs are unlikely to benefit from inclusion.
Why it matters
Potential benefit: If successful, this could offer a more biocompatible pulpotomy material and a tooth-colored 3D-printed crown option for primary molars.
How similar studies have performed: MTA has strong clinical evidence for pulpotomy success, while bioceramic putties and 3D-printed resin crowns have promising but more limited and shorter-term data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Children aged from 5 to 7 years. 2. Medically healthy children (ASA I) (Appendix I) 3. Positive or definitely positive behavior (Frankl's rating scale scores III or IV) (Appendix II) 4. Parents/legal guardians who provide written informed consent Tooth inclusion criteria(8, 14, 31)
1. Deep carious second primary molars with:
1. Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection.
2. Signs of reversible pulpitis. 10
2. Require full coverage restorations
3. Cooperative children (Frankl 3 or 4 behavior rating scale)
Exclusion Criteria:
* History of spontaneous pain. 2. Tooth mobility. 3. Excessive bleeding from radicular stumps after coronal pulp amputation. 4. Radiographic evidence of pathological root resorption, inter-radicular bone loss, periapical pathology, or canal calcifications. 5. Previous dental treatment of the involved molar. 6. Children with special healthcare needs.
Where this trial is running
Alexandria
- Faculty of Dentistry, Alexandria University, Egypt — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: yousr nader pediatric dentist specialist, doctorate
- Email: yousr.nader@gmail.com
- Phone: yousr.nader@gmail.com
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.