Stomatognathic System Assesment, After Different Methods of Establishing the Centric Relation

June 21, 2019 updated by: Aleksandra Nitecka-Buchta, Medical University of Silesia

Functional Assessment of the Stomatognathic System, After the Treatment of Edentulous Patients, With Different Methods of Establishing the Centric Relation

Patients with complete dentures were examined after the prosthoddontic treatment with two methods of establishing a centric relation: wax rims and gothic arch tracing method. The effectiveness of establishing a centric relation was evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the study subjective experiences of patients, wearing complete dentures, were compared. Two different methods of determining a centric relation were performed: the traditional method using wax occlusal rims and the Gerber method, based on gothic arch tracings. The success rate of establishing a centric relation in both methods was evaluated (rentgenodiagnostics). The influence of the method used to obtain the centric relation on patients stomatognathic system (condyle centralization, pain) was also evaluated. The comparison between two methods was performed and results were analyzed. A centric relation was analyzed in temporomandibular joints and a corelation between TMD symptoms and centric relation was evaluated.

Study Type

Observational

Enrollment (Actual)

72

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

  • Poland
      • Zabrze, Poland, 41-800
        • Department of TMD and Orthodontics Silesian Medical 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

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients attending dental office in Germany and in Poland, seeking for dental intervention: complete denture

Description

Inclusion Criteria:

  • TMD according to RDC/TMD group I ,II
  • Edentulous patients wearing complete dentures
  • Patients agreement for taking part in the study

Exclusion Criteria:

  • Analgesic drug addicted patients
  • Neurological diseases with headache (migraine, cluster headache)
  • Trauma in the head and neck region in the past 2 years

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
Traditional CR establishing
establishing a CR in traditional way with occlusal wax rims during complete dentures therapy
Procedure: complete dentures
therapy with maxilla and mandible dentures
Gothic arch method
establishing a CR with gothic arch tracing device during complete dentures therapy
Procedure: complete dentures
therapy with maxilla and mandible dentures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mandible condyles centralisation in temporomandibular joints
Time Frame: 1 year
mandible condylecentral position
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity changes in Visual Analogue Scale
Time Frame: 1 year
subjective pain intensity 0-10 points
1 year
Anamnestic Index
Time Frame: 1 year
Evaluation of an anamnestic index according to Helkimo
1 year
Dysfunction Index
Time Frame: 1 year
Evaluation of an dysfunction index
1 year

Collaborators and Investigators

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

Sponsor

Medical University of Silesia

Investigators

  • Study Director: Stefan Baron, Profesor, Department of Temporomandibular Disorders and Orthodontics

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 24, 2014

Primary Completion (ACTUAL)

February 20, 2016

Study Completion (ACTUAL)

February 20, 2017

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mandible centralisation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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