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NCT05087147 Clinical Trial

Clinical Evaluation of Bonded Versus Banded Space Maintainers

Tooth Loss Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05087147
Other study ID # space maintainer
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date September 1, 2023

Study information
Verified date May 2022
Source Cairo University
Contact Omar S Abo El Abbas
Phone 0225196520
Email omar_aboelabbas0107@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing bonded space maintainers to banded space maintainers

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date September 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 0.7 mm stainless steel orthodontic wire
0.7 mm stainless steel orthodontic wire
• Banded space maintainer
band and loop space maintainer

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Omar Sherif Ahmed Abo El Abbas

Outcome
Type Measure Description Time frame Safety issue
Primary appliance failure Patient reported up to 12 months
Secondary Radiographic space loss in millimeters up to 12 months
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