Clinical Evaluation of Bonded Versus Banded Space Maintainers

NCT ID: NCT05087147

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-09-01

Brief Summary

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Comparing bonded space maintainers to banded space maintainers

Detailed Description

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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.

Conditions

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Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Statisticians

Study Groups

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Bonded space maintainer

Wire bonded with composite to abutment teeth

Group Type EXPERIMENTAL

0.7 mm stainless steel orthodontic wire

Intervention Type DEVICE

0.7 mm stainless steel orthodontic wire

Banded space maintainer

Band and loop space maintainer

Group Type ACTIVE_COMPARATOR

Banded space maintainer

Intervention Type DEVICE

band and loop space maintainer

Interventions

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0.7 mm stainless steel orthodontic wire

0.7 mm stainless steel orthodontic wire

Intervention Type DEVICE

Banded space maintainer

band and loop space maintainer

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Omar Sherif Ahmed Abo El Abbas

OTHER

Sponsor Role lead

Responsible Party

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Omar Sherif Ahmed Abo El Abbas

Assistant Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Omar S Abo El Abbas

Role: PRINCIPAL_INVESTIGATOR

Cairo U

Central Contacts

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Omar S Abo El Abbas

Role: CONTACT

0225196520 ext. Manial

Other Identifiers

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space maintainer

Identifier Type: -

Identifier Source: org_study_id

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