Department of Pediatric Dentistry, Mansoura University
Al Mansurah, Dakahleya Governorate, 35511, Egypt
NCT Number: NCT05693870
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.
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Notify Me4 year–8 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahleya Governorate, 35511, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other names: Bonded or/ Banded space maintainers
Time frame: 15 months
Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
Mansoura University
Other
Clinical Evaluation of Different Designs of Fixed Space Maintainer. A Randomized Clinical Trial
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