Different Designs of Space Maintainer

January 20, 2023 updated by: Mansoura University

Clinical Evaluation of Different Designs of Fixed Space Maintainer. A Randomized Clinical Trial

Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.

Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B&L), Group II: Single-sided band and loop (Ss B&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T&L). children were recalled at 3, 6, 9, 12,15-month.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: Evaluation of survival rate for three space maintainers (SMs) of different designs versus standard one.

Methods: 52 extraction sites in children of age group of 4-7 years with prematurely-lost 1st primary molar were selected for this study. The whole sample was divided into four groups (13 each). In Group I, Band and loop (B&L), Group II: Single-sided band and loop (Ss B&L), Group III: Direct bonded wire (DBW), Group IV: Tube and loop (T&L). children were recalled at 3, 6, 9, 12,15-month. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Cumulative survival rates of SMs were estimated by means of Kaplan-Meier method with log rank test. Sample size: The total sample size was calculated using Sampsize application with anticipated success on treatment with conventional band and loop 86% , anticipated response on treatment with direct bonded wire 33% 12, at 80% power, and significant level 0.05.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahleya Governorate
      • Mansoura, Dakahleya Governorate, Egypt, 35511
        • Department of Pediatric Dentistry, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children and their parents showed cooperation and compliance.
  2. Extraction of the first primary molar was not exceeding three months.
  3. Angle's class 1 occlusion with normal deciduous molar relation
  4. Child not complaining from any systemic disease.
  5. The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
  6. Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
  7. No restorative application on the buccal surfaces of abutment teeth, otherwise extra-coronal complete coverage, as stainless-steel crown, was applied only in banded groups.
  8. Radiographically, presence of permanent successor.
  9. Absence of any pathological evidence on the eruption track of the permanent tooth.
  10. Ability to attend follow-up appointments as required.

Exclusion Criteria:

  1. Child complaining from any systemic disease.
  2. Prescence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite
  3. Extraction of the first primary molar was exceeding three months.
  4. The extraction space resulted from more than one missing deciduous molar
  5. Radiographically, absence of permanent successor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (B&L)
13 Band and loop (B&L) appliance were included in group one
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
  • Bonded or/ Banded space maintainers
Experimental: Group II (Ssb&l)
13 Single-sided Band and loop (SsB&L) appliance were included in group two
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
  • Bonded or/ Banded space maintainers
Experimental: Group III (DBW)
13 Direct Bonded Wire (DBW) appliance were included in group three
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
  • Bonded or/ Banded space maintainers
Experimental: Group IV(T&L)
13 Tube and Loop (T&L) appliance were included in group four
Device: Fixed space maintainer
Appliance bonded with composite resin or/banded and cemented with glass ionomer cement
Other Names:
  • Bonded or/ Banded space maintainers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median survival rate
Time Frame: 15 months
Cumulative survival rates of space maintainers were estimated by means of Kaplan-Meier method with log rank test
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Ibrahem H Elkalla, Professor, Department of Pediatric Dentistry Department, Mansoura University, Mansoura, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

January 3, 2022

Study Completion (Actual)

November 5, 2022

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A27080120

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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