Different Designs of Space Maintainer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Different Designs of Fixed Space Maintainer. A Randomized Clinical Trial

Conditions
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Early Tooth Exfoliation

Intervention / Treatment
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* Device: Fixed space maintainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (B&L)<br>13 Band and loop (B&L) appliance were included in group one | Device: Fixed space maintainer<br>* Appliance bonded with composite resin or/banded and cemented with glass ionomer cement<br>* Other names: Bonded or/ Banded space maintainers;|
| Experimental: Group II (Ssb&l)<br>13 Single-sided Band and loop (SsB&L) appliance were included in group two | Device: Fixed space maintainer<br>* Appliance bonded with composite resin or/banded and cemented with glass ionomer cement<br>* Other names: Bonded or/ Banded space maintainers;|
| Experimental: Group III (DBW)<br>13 Direct Bonded Wire (DBW) appliance were included in group three | Device: Fixed space maintainer<br>* Appliance bonded with composite resin or/banded and cemented with glass ionomer cement<br>* Other names: Bonded or/ Banded space maintainers;|
| Experimental: Group IV(T&L)<br>13 Tube and Loop (T&L) appliance were included in group four | Device: Fixed space maintainer<br>* Appliance bonded with composite resin or/banded and cemented with glass ionomer cement<br>* Other names: Bonded or/ Banded space maintainers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median survival rate | Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test | 15 months |