Different Designs of Space Maintainer
- Conditions
- Early Tooth Exfoliation
- Interventions
- Device: Fixed space maintainer
- Registration Number
- NCT05693870
- Lead Sponsor
- Mansoura University
- Brief Summary
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month.
- Detailed Description
Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.
Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B\&L), Group II: Single-sided band and loop (Ss B\&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T\&L). children were recalled at 3, 6, 9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated using Sampsize application with anticipated success on treatment with conventional band and loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power, and significant level 0.05.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Children and their parents showed cooperation and compliance.
- Extraction of the first primary molar was not exceeding three months.
- Angle's class 1 occlusion with normal deciduous molar relation
- Child not complaining from any systemic disease.
- The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
- Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
- No restorative application on the buccal surfaces of abutment teeth, otherwise extra-coronal complete coverage, as stainless-steel crown, was applied only in banded groups.
- Radiographically, presence of permanent successor.
- Absence of any pathological evidence on the eruption track of the permanent tooth.
- Ability to attend follow-up appointments as required.
- Child complaining from any systemic disease.
- Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
- Extraction of the first primary molar was exceeding three months.
- The extraction space resulted from more than one missing deciduous molar
- Radiographically, absence of permanent successor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group III (DBW) Fixed space maintainer 13 Direct Bonded Wire (DBW) appliance were included in group three Group II (Ssb&l) Fixed space maintainer 13 Single-sided Band and loop (SsB\&L) appliance were included in group two Group IV(T&L) Fixed space maintainer 13 Tube and Loop (T\&L) appliance were included in group four Group I (B&L) Fixed space maintainer 13 Band and loop (B\&L) appliance were included in group one
- Primary Outcome Measures
Name Time Method Median survival rate 15 months Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Pediatric Dentistry, Mansoura University
🇪🇬Mansoura, Dakahleya Governorate, Egypt