Comparing different types of crowns for children's molars after pulp treatment
Clinical Evaluation of Digital Versus Prefabricated Primary Crowns For Restoration of Pulpotomized Primary Molars: A Randomized Clinical Trial
This study is testing which type of crown works best for kids aged 5 to 9 with treated molars to see which one lasts longer and makes both kids and parents happier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 5 Years to 9 Years |
| Sex | All |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 1 site (El-Sheikh Zayed City, Giza) |
| Trial ID | NCT06733909 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the clinical outcomes of three types of crowns—NuSmile Zirconia crowns, BioFlx crowns, and Digital VITA ENAMIC crowns—used for restoring pulpotomized primary molars in children aged 5 to 9 years. The study aims to assess the effectiveness, durability, and parental satisfaction associated with each crown type. Participants will be children with restorable primary molars who are cooperative and have no significant pain or systemic diseases. The trial will provide insights into which crown type offers the best clinical and aesthetic results for young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 9 years with restorable pulpotomized primary molars who are cooperative during dental procedures.
Not a fit: Patients with systemic diseases, uncooperative behavior, or un-restorable primary molars will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental restoration options for children, enhancing both functionality and aesthetics of primary molars.
How similar studies have performed: Previous studies have shown positive outcomes with similar types of crowns, indicating a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children aged between 5 and 9 years old. 2. Positively cooperative children. 3. Children having a restorable pulpotomized primary tooth. 4. Primary molars with no spontaneous or provoked pain 5. Teeth to be included should be fully erupted, have functional occlusion. 6. The crowned molar is in contact with at least one adjacent molar medially with primary first molar and- or laterally with permanent first molar (standard for posterior crowns). 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. The child having oral parafunctional habits 4. 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
- MSA University — El-Sheikh Zayed City, Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwa 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.