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Clinical Evaluation of Bonded Versus Banded Space Maintainers

Primary Purpose

Tooth Loss

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

0.7 mm stainless steel orthodontic wire

Banded space maintainer

About this trial

This is an interventional prevention trial for Tooth Loss

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bonded space maintainer

Banded space maintainer

Arm Description

Wire bonded with composite to abutment teeth

Band and loop space maintainer

Outcomes

Primary Outcome Measures

appliance failure

Patient reported

Secondary Outcome Measures

Radiographic space loss

in millimeters

Full Information

NCT ID

NCT05087147

First Posted

September 27, 2021

Last Updated

May 15, 2022

Sponsor

Omar Sherif Ahmed Abo El Abbas

1. Study Identification

Unique Protocol Identification Number

NCT05087147

Brief Title

Clinical Evaluation of Bonded Versus Banded Space Maintainers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Omar Sherif Ahmed Abo El Abbas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Statisticians

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bonded space maintainer

Arm Type

Experimental

Arm Description

Wire bonded with composite to abutment teeth

Arm Title

Banded space maintainer

Arm Type

Active Comparator

Arm Description

Band and loop space maintainer

Intervention Type

Device

Intervention Name(s)

0.7 mm stainless steel orthodontic wire

Intervention Description

0.7 mm stainless steel orthodontic wire

Intervention Type

Device

Intervention Name(s)

Banded space maintainer

Intervention Description

band and loop space maintainer

Primary Outcome Measure Information:

Title

appliance failure

Description

Patient reported

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Radiographic space loss

Description

in millimeters

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Omar S Abo El Abbas

Phone

0225196520

Ext

Manial

omar_aboelabbas0107@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omar S Abo El Abbas

Organizational Affiliation

Cairo U

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Evaluation of Bonded Versus Banded Space Maintainers

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