Different Designs of Space Maintainer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (B&L) 13 Band and loop (B&L) appliance were included in group one |
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
|
| Experimental: Group II (Ssb&l) 13 Single-sided Band and loop (SsB&L) appliance were included in group two |
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
|
| Experimental: Group III (DBW) 13 Direct Bonded Wire (DBW) appliance were included in group three |
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
|
| Experimental: Group IV(T&L) 13 Tube and Loop (T&L) appliance were included in group four |
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Median survival rate [15 months]
Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children and their parents showed cooperation and compliance.
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Extraction of the first primary molar was not exceeding three months.
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Angle's class 1 occlusion with normal deciduous molar relation
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Child not complaining from any systemic disease.
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The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
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Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
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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.
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Radiographically, presence of permanent successor.
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Absence of any pathological evidence on the eruption track of the permanent tooth.
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Ability to attend follow-up appointments as required.
Exclusion Criteria:
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Child complaining from any systemic disease.
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Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
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Extraction of the first primary molar was exceeding three months.
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The extraction space resulted from more than one missing deciduous molar
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Radiographically, absence of permanent successor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pediatric Dentistry, Mansoura University | Mansoura | Dakahleya Governorate | Egypt | 35511 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Study Director: Ibrahem H Elkalla, Professor, Department of Pediatric Dentistry Department, Mansoura University, Mansoura, Egypt
Study Documents (Full-Text)
None provided.More Information
Publications
- Gulec S, Dogan MC, Seydaoglu G. Clinical evaluation of a new bonded space maintainer. J Clin Orthod. 2014 Dec;48(12):784-90. No abstract available.
- Tunc ES, Bayrak S, Tuloglu N, Egilmez T, Isci D. Evaluation of survival of 3 different fixed space maintainers. Pediatr Dent. 2012 Jul-Aug;34(4):e97-102.
- A27080120