Comparing 3D printed and conventionally made space maintainers for children's dental health
Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
This study is testing if 3D printed space maintainers work better than traditional ones for children who need dental treatment after losing their baby teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 5 Years to 8 Years |
| Sex | All |
| Sponsor | Aydin Adnan Menderes University Academic / other |
| Locations | 1 site (Aydin, Aydın) |
| Trial ID | NCT06798090 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of band and loop space maintainers produced using three-dimensional printing technology compared to those made using conventional techniques. The study will involve systemically healthy children who require the extraction of bilateral lower deciduous first molars and the application of space maintainers. A split-mouth design will be used, where one side will receive a 3D printed maintainer and the other a conventional one, allowing for direct comparison of clinical success and effects on periodontal tissues over an 18-month follow-up period. Key metrics for evaluation will include appliance survival, failure criteria, and periodontal health indicators.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy children needing bilateral lower deciduous first molar extractions and space maintainers.
Not a fit: Patients with systemic diseases or those rated with a Frankl score of 1 or 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental treatment options for children, enhancing the effectiveness and comfort of space maintainers.
How similar studies have performed: While the use of 3D printing in dentistry is gaining traction, this specific comparison of 3D printed versus conventional space maintainers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy children * Bilateral early loss of deciduous first molar teeth in the lower jaw * Presence of radiographically confirmed permanent tooth germ under the extracted deciduous tooth * Radiographically determined 1,5 mm minimum of bone existence above the permanent tooth germ * Existence of flush terminal plane/mesial step in decidious dentition and Angle class 1 molar relationship in mixed dentition * Existence of radiographically and clinically healthy abutment teeth * Frankl score 3 and 4 children Exclusion Criteria: * Patients with systemic diseases * Frankl score 1 and 2 children
Where this trial is running
Aydin, Aydın
- Aydın Adnan Menderes University — Aydin, Aydın, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sultan Keles, Associate Proffesor
- Email: dtsultank@gmail.com
- Phone: +905318438557
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.