Clinical Evaluation of Bonded Versus Banded Space Maintainers

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

Comparing bonded space maintainers to banded space maintainers

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Device: 0.7 mm stainless steel orthodontic wire; Device: Banded space maintainer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar S Abo El Abbas; Phone Number: Manial 0225196520; Email: omar_aboelabbas0107@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bonded space maintainer; Wire bonded with composite to abutment teeth	Device: 0.7 mm stainless steel orthodontic wire; 0.7 mm stainless steel orthodontic wire
ACTIVE_COMPARATOR: Banded space maintainer; Band and loop space maintainer	Device: Banded space maintainer; band and loop space maintainer

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

Collaborators and Investigators

• Sponsor: Omar Sherif Ahmed Abo El Abbas
• Investigators: Principal Investigator: Omar S Abo El Abbas, cairo U

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (ACTUAL): October 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: Space maintainer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No