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

Completed

• Conditions: Temporomandibular Disorders
• Interventions: Procedure: complete dentures

• Registration Number: NCT03343015
• Lead Sponsor: Medical University of Silesia

Brief Summary

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.

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 Timeline

• Study Start: 2014-02-24
• Primary Completion: 2016-02-20
• Study Completion: 2017-02-20
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gothic arch method	complete dentures	establishing a CR with gothic arch tracing device during complete dentures therapy
Traditional CR establishing	complete dentures	establishing a CR in traditional way with occlusal wax rims during complete dentures therapy

Primary Outcome Measures

Name	Time	Method
Mandible condyles centralisation in temporomandibular joints	1 year	mandible condylecentral position

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of TMD and Orthodontics Silesian Medical University; 🇵🇱 Zabrze, Poland