Clinical trial NCT03343015: Stomatognathic System Assesment, After Different Methods of Establishing the Centric Relation
Official title: Functional Assessment of the Stomatognathic System, After the Treatment of Edentulous Patients, With Different Methods of Establishing the Centric Relation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders
Keywords: TMD, centric relation, complete dentures
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending dental office in Germany and in Poland, seeking for dental intervention: complete denture

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mandible condyles centralisation in temporomandibular joints
timeFrame: 1 year
Secondary outcomes:
measure: Pain intensity changes in Visual Analogue Scale
timeFrame: 1 year
measure: Anamnestic Index
timeFrame: 1 year
measure: Dysfunction Index
timeFrame: 1 year
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of TMD and Orthodontics Silesian Medical University
Study officials:
affiliation: Department of Temporomandibular Disorders and Orthodontics
name: Stefan Baron, Profesor
role: STUDY_DIRECTOR
References:
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citation: Nitecka-Buchta A, Proba T, Proba P, Stefanski K, Baron S. Functional Assessment of the Stomatognathic System, after the Treatment of Edentulous Patients, with Different Methods of Establishing the Centric Relation. Pain Res Manag. 2018 Feb 4;2018:1572037. doi: 10.1155/2018/1572037. eCollection 2018.