Comparing two types of aesthetic space maintainers for children
Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)
This study is testing two types of dental space maintainers made from different materials to see which one works better for kids who have had their back baby teeth removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06558968 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance of two types of aesthetic space maintainers made from Polyetheretherketone (PEEK) and monolithic Zirconia (BruxZir) in children who have undergone bilateral extraction of mandibular first primary molars. The research involves taking impressions of the dental arches, fabricating the space maintainers using CAD/CAM technology, and monitoring their performance over a one-year period. Key metrics include the frequency of debonding or fracture of the appliances and the health of adjacent gingiva, as well as the wear on opposing teeth.
Who should consider this trial
Good fit: Ideal candidates are children needing bilateral extraction of mandibular first primary molars with healthy adjacent teeth.
Not a fit: Patients with carious abutment teeth, bruxism, or other dental abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved aesthetic and functional outcomes for children requiring space maintainers.
How similar studies have performed: While there is limited data on the specific materials being compared, similar studies have shown promise in the use of aesthetic materials in pediatric dentistry.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical inclusion criteria: * Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) . * Existence of teeth on the mesial and distal side of edentulous area. * Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion Radiographic inclusion criteria: * No periapical and/ or furcural pathological condition related to abutment teeth. * Presence of tooth germ of the succeeding tooth (mandibular first premolars). * Presence of more than 1 mm of bone overlying the successor tooth germ Exclusion Criteria: * Carious abutment teeth requiring pulp therapy. * Carious abutment primary teeth requiring a full coverage restoration. * Patients with history of bruxism or/and clenching. * Patients with medical, intellectual or physical disabilities. * Patients with abnormalities as posterior cross-bite, open bite, and deep bite
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Hagar Abozeid, PhD
- Email: Hagar_abozeid_22@hotmail.com
- Phone: 0201110611169
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.