Clinical Evaluation of Bonded Versus Banded Space Maintainers

Study Overview
=================
Brief Summary
-----------------
Comparing bonded space maintainers to banded space maintainers

Detailed Description
-----------------
Comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. Finally, patient satisfaction regarding both treatments.

Official Title
-----------------
Clinical Evaluation of Bonded Versus Banded Space Maintainers in Children With Prematurely Lost First Primary Molars: A Randomized Controlled Clinical Trial

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Device: 0.7 mm stainless steel orthodontic wire
* Device: Banded space maintainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy. Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space. Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars. Exclusion criteria: Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bonded space maintainer<br>Wire bonded with composite to abutment teeth | Device: 0.7 mm stainless steel orthodontic wire<br>* 0.7 mm stainless steel orthodontic wire<br>|
| Active Comparator: Banded space maintainer<br>Band and loop space maintainer | Device: Banded space maintainer<br>* band and loop space maintainer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appliance failure | Patient reported | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic space loss | in millimeters | up to 12 months |