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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05087147

Enrollment

Registered

2021-10-21

Start date

2022-07-01

Completion date

2023-09-01

Last updated

2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Loss

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.

Interventions

DEVICE0.7 mm stainless steel orthodontic wire

0.7 mm stainless steel orthodontic wire

DEVICEBanded space maintainer

band and loop space maintainer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Masking description

Statisticians

Eligibility

Sex/Gender

ALL

Age

6 Years to 8 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
appliance failure	up to 12 months	Patient reported

Secondary

Measure	Time frame	Description
Radiographic space loss	up to 12 months	in millimeters

Contacts

Primary ContactOmar S Abo El Abbas

omar_aboelabbas0107@yahoo.com0225196520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026