Evaluation of a 3-D printed partial denture for children
Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer and Its Impact on Children's Oral Health Status: A Randomized Controlled Clinical Crossover Study
This study tests a new 3-D printed partial denture for kids who lost their baby molars early to see if it can help keep space for their adult teeth and support healthy gums.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 9 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Tanta and 1 other locations) |
| Trial ID | NCT06825273 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on the use of a 3-D printed partial denture space maintainer designed for children who have lost their primary molars prematurely. The study aims to assess the effectiveness of this innovative approach in maintaining space for permanent teeth and promoting gingival health. By utilizing digital technology, the study seeks to enhance the reliability and durability of space maintainers while reducing the time required for manual manufacturing. The target population includes healthy children who meet specific eligibility criteria related to their dental health and cooperation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children who have recently lost lower primary molars and are expected to have their permanent successors erupt within a specific timeframe.
Not a fit: Patients who exhibit poor oral hygiene, have abnormal occlusion conditions, or are uncooperative may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more efficient and effective solution for preventing malocclusions in children who have lost primary teeth.
How similar studies have performed: While the use of digital technology in pediatric dentistry is advancing, this specific application of 3-D printed space maintainers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * apparently, healthy cooperative children having recent premature loss of lower primary molars * the permanent successors of the lost primary molars were not expected to erupt within 6 months * Angle's class 1 occlusion with normal primary molar relation * Presence of teeth on the mesial and distal side of the edentulous area * Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite. * Radiographically, presence of permanent successors. * parents and children were accepting the new treatment modality. Exclusion Criteria: * children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion * Extraction of primary molars exceeding three months. * Radiographically, absence of permanent successor. * uncooperative children
Where this trial is running
Tanta and 1 other locations
- pediatric dentistry department, faculty of dentistry, Tanta university — Tanta, Egypt (Recruiting)
- Tanta University — Tanta, Egypt (Not_yet_recruiting)
Study contacts
- Study coordinator: shaimaa eldesouky, assistant professor
- Email: shaimaaeldesouky@dent.tanta.edu.eg
- Phone: +201008994242
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.