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Clinical Evaluation of Bonded Versus Banded Space Maintainers

Sponsor
Omar Sherif Ahmed Abo El Abbas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05087147
Collaborator
(none)
36
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparing bonded space maintainers to banded space maintainers

Condition or Disease Intervention/Treatment Phase
  • Device: 0.7 mm stainless steel orthodontic wire
  • Device: Banded space maintainer
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Statisticians
Primary Purpose:
Prevention
Official Title:
Clinical Evaluation of Bonded Versus Banded Space Maintainers in Children With Prematurely Lost First Primary Molars: A Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. appliance failure [up to 12 months]

    Patient reported

Secondary Outcome Measures

  1. Radiographic space loss [up to 12 months]

    in millimeters

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Omar Sherif Ahmed Abo El Abbas

Investigators

  • Principal Investigator: Omar S Abo El Abbas, Cairo U

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omar Sherif Ahmed Abo El Abbas, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT05087147
Other Study ID Numbers:
  • space maintainer
First Posted:
Oct 21, 2021
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tooth Loss

Study Results

No Results Posted as of May 17, 2022