Clinical and Radiographic Evaluation of Different Thickness of Vacuum Formed Retainer (Essix Retainer) During Retention Phase After Orthodontic Treatment

October 30, 2019 updated by: Mostafa Ahmed, Minia University
vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

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

15 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients that have finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders

Description

Inclusion Criteria:

  • patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
  • patients indicated for removable retainer

Exclusion Criteria:

  • any systemic disease
  • chronic medication uptake
  • bad oral hygiene pathological conditions of temporomandibular joint

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1 (Wrapround retainer)
Orthodontic retainer
Group 2 (Essix retainer 1mm)
Group 3 (Essix retainer 1.5 mm)
Group 3 (Essix retainer 2mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effect of retainer on temporomandibular joint
Time Frame: 9 months
Absence of pain, deviation and trismus
9 months
Radiographic effect of retainer on tempromandibular joint
Time Frame: 9 months
Normal dissc position
9 months

Collaborators and Investigators

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

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 (ANTICIPATED)

October 29, 2019

Primary Completion (ANTICIPATED)

August 25, 2020

Study Completion (ANTICIPATED)

October 25, 2020

Study Registration Dates

First Submitted

October 27, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (ACTUAL)

November 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

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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