Evaluating a new pulp treatment for children's primary molars
Official title: Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol: A Randomized Clinical Trial.
Run by October University for Modern Sciences and Arts · NCT06288477 · Data updated 2026-11-12
This study is testing a new dental treatment for kids aged 4 to 9 to see if a special material called Neo-Putty® works better than the usual method for saving their baby teeth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 9 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 1 site (El-Sheikh Zayed City, Giza Governorate) |
| Status | Recruiting |
| Started | March 20, 2024 |
| Main results expected | May 1, 2024 |
| Study ends | February 1, 2025 |
| Registry record updated | December 20, 2024 |
| Trial ID | NCT06288477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 4 to 9 with healthy primary molars that do not exhibit pain or signs of root resorption.
✕Probably not a fit
Patients with systemic diseases or un-restorable primary molars will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of a novel bioactive bioceramic material, Neo-Putty®, against traditional formocresol in performing vital pulpotomy on primary molars in children aged 4 to 9. The study will assess both clinical and radiographic outcomes to determine the safety and efficacy of Neo-Putty® in promoting healing and regeneration of radicular pulp tissue. By utilizing a randomized approach, the trial seeks to provide robust data on the potential benefits of this new treatment method over conventional practices.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatment options for pediatric dental patients undergoing pulpotomy.
How similar studies have gone: While traditional methods like formocresol have been widely used, the introduction of bioactive materials like Neo-Putty® represents a novel approach that has not been extensively tested in clinical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Criteria The eligibility criteria were set according to the guidelines of AAPD, 2020. (4) Inclusion Criteria: 1. 4 -9 years old 2. Primary molars with no spontaneous or provoked pain 3. Primary molars with at least two-thirds of the root length were still present. 4. Primary molars with no sign of internal or other kinds of root or bone resorption. Exclusion Criteria: 1. Patients with systemic diseases (congenital or rheumatic heart disease, hepatitis, nephritis, tumor, cyclic neutropenia, leukemia, and children on long-term corticosteroid therapy). 2. Un-cooperative patients. 3. Un-restorable primary molars (Grossly broken-down primary molars that have decay extending way under the gingiva and tooth with root caries).
Where it's running
-
MSA University
El-Sheikh Zayed City, Giza Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Marwa A Salamon, Ph.D
- Email: maasalmon@msa.edu.eg
- Phone: +20 101 655 5055
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.