- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149366
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 295
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.
Clinical Trials on Temporomandibular Joint Disorders After Using Essix Retainer
-
Lund University HospitalLund UniversityRecruitingTemporomandibular Disorders (TMD) | Temporomandibular Joint AnkylosisSweden
-
Mansoura UniversityCompletedTemporomandibular Joint Disc Displacement | Internal Derangement of the Tempromandibular Joint | Temporomandibular Disorders (TMDs) | Myogenic Temporomandibular Joint DisordersEgypt
-
Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyCompletedTemporomandibular Joint Disorders | Temporomandibular Joint Dysfunction Syndrome | Temporomandibular Disorder | Temporomandibular Joint Pain | Manual Therapy | Temporomandibular Joint Disc DisplacementTurkey
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Karolinska InstitutetKarolinska University Hospital; EastmaninstitutetRecruitingTemporomandibular Disorders (TMD) | Temporomandibular Joint Disc Displacement | Temporomandibular Joint Disc Displacement, Without ReductionSweden
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B.P. Koirala Institute of Health SciencesCompletedTemporomandibular Joint Disorder | Temporomandibular Disorders (TMD)Nepal
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TC Erciyes UniversityRecruitingTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Pain | Temporomandibular Joint Osteoarthritis | Temporomandibular Joint EffusionTurkey
-
McGill University Health Centre/Research Institute...Not yet recruitingTemporomandibular Joint | Temporomandibular Dysfunction (TMD) | Temporomandibular Joint and Muscle Disorder | Temporo-mandibular Dysfunction | Temporomandibular Disorder (TMD) | Temporomandibular Disorders (TMDs)Canada
-
Suez Canal UniversityCompletedTemporomandibular Joint Disorders | Temporomandibular Disorders (TMD) | TMJ Pain | Temporomandibular Joint Internal DerangementEgypt
-
Karolinska InstitutetKarolinska University HospitalRecruitingTemporomandibular Disorders (TMD) | Temporomandibular Joint Disc Displacement, Without Reduction | Temporomandibular Joint Disc Displacement, With ReductionSweden
-
Helin Merve ÖzalpCompletedTemporomandibular Disorders (TMD) | Temporomandibular Joint Disc Displacement, With ReductionTurkey (Türkiye)
Clinical Trials on Retainer
-
Region GävleborgUmeå UniversityCompletedOrthodontics | Retention
-
University of MalayaUnknownBimaxillary ProclinationMalaysia
-
Universidad Rey Juan CarlosCompletedPatient Satisfaction | Tooth Sensitivity | Bleaching Efficacy | Gingival IrritationSpain
-
King Abdulaziz UniversityRecruitingOrthodontic Appliance Complication | Orthodontic Appliance Design | Orthodontic TreatmentSaudi Arabia
-
Poliklinika OrthonovaUniversity of Zagreb School of Dental Medicine, Zagreb, Croatia; University...RecruitingOrthodontic RelapseCroatia
-
Hacettepe UniversityCompleted
-
University of Sao PauloCompleted
-
Cairo UniversityRecruitingOrthodontic Appliance ComplicationEgypt
-
Essraa hassan Hussein MohamedNot yet recruitingOrthodontic Retention Appliance | Clear Orthodontic RetainersEgypt
-
Postgraduate Institute of Dental Sciences RohtakRecruiting