Evaluating a new pulp treatment for children's primary molars
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 1 site (El-Sheikh Zayed City, Giza Governorate) |
| Trial ID | NCT06288477 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with systemic diseases or un-restorable primary molars will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
El-Sheikh Zayed City, Giza Governorate
- 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
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.