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"Evaluation of Clinical Performance and Success Rate of CAD/CAM Versus Conventional Band and Loop Space Maintainer"

NCT05134714 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-01-31

No results posted yet for this study

Summary

This study is to evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits and gingival health and, the success rate of the appliances in terms of: survival time, cement loss and appliance breakage. And to compare both appliances in terms of patient satisfaction.

This study consists of two parts: in vivo part (split mouth RCT) and in vitro part:

In vivo study:

Its sample size was found to be (36) cases (i.e. 18 case per group). Sample size calculation was performed using G\*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out.

In this in vivo study split mouth will be randomly divided into two groups:

Group 1: Conventional metal band and loop space maintainer Group 2: CAD/CAM zircon band and loop space maintainer

In vitro study:

its sample size was found to be (24) samples (i.e. 8 samples per group). Sample size calculation was performed using G\*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out.

Grouping:

The zirconia specimen divided randomly into three groups according to type of cements:

Group 1: Self-adhesive resin cement Group 2: Resin-modified glass ionomer cement Group 3: Universal bioactive cement

Conditions

  • CAD/CAM Space Maintainer

Interventions

DEVICE

CAD/CAM zircon band and loop space maintainer

Solid monolithic zirconia material which utilizes CAD/CAM technology for its designing and milling of the restoration will be used for fabrication of the space maintainer.

DEVICE

Conventional metal band and loop space maintainer

Stainless steel appropriate band will be selected according to the size of the abutment teeth and then design of the loop will be obtained, then will be send to the laboratory for soldering.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Gehan G. Allam, PHD · Ain Shams Univesity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-11-01
Completion
2024-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134714 on ClinicalTrials.gov