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Completed

NCT Number: NCT05693870

Different Designs of Space Maintainer

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Dentistry, Mansoura University

Al Mansurah, Dakahleya Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and their parents showed cooperation and compliance.
  • Extraction of the first primary molar was not exceeding three months.
  • Angle's class 1 occlusion with normal deciduous molar relation
  • Child not complaining from any systemic disease.
  • The extraction space was of only one missing first deciduous molar with remaining teeth present on mesial and distal side of extraction space.
  • Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, deep bite.
  • 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.
  • Radiographically, presence of permanent successor.
  • Absence of any pathological evidence on the eruption track of the permanent tooth.
  • Ability to attend follow-up appointments as required.

Exclusion criteria

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

Treatment and study plan

Fixed space maintainer

Device

Appliance bonded with composite resin or/banded and cemented with glass ionomer cement

Other names: Bonded or/ Banded space maintainers

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2023
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.