Different Designs of Space Maintainer

Mansoura University52 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Early Tooth Exfoliation

Interventions

Fixed space maintainerDEVICE

Appliance bonded with composite resin or/banded and cemented with glass ionomer cement

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children and their parents showed cooperation and compliance. 2. Extraction of the first primary molar was not exceeding three months. 3. Angle's class 1 occlusion with normal deciduous molar relation 4. Child not complaining from any systemic disease. 5. The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space. 6. Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite. 7. 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. 8. Radiographically, presence of permanent successor. 9. Absence of any pathological evidence on the eruption track of the permanent tooth. 10. Ability to attend follow-up appointments as required. Exclusion Criteria: 1. Child complaining from any systemic disease. 2. Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite 3. Extraction of the first primary molar was exceeding three months. 4. The extraction space resulted from more than one missing deciduous molar 5. Radiographically, absence of permanent successor.

Locations (1)

Department of Pediatric Dentistry, Mansoura University

Al Mansurah, Dakahleya Governorate, Egypt

Outcomes

Primary Outcomes

Median survival rate

Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test

Time frame: 15 months

Data from ClinicalTrials.gov

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