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

Temporomandibular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343015
• Other study ID #: Mandible centralisation
• Status: Completed
• Start date: February 24, 2014
• Est. completion date: February 20, 2017

Study information

• Verified date: June 2019
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 20, 2017
• Est. primary completion date: February 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• complete dentures
therapy with maxilla and mandible dentures

Locations

Country	Name	City	State
Poland	Department of TMD and Orthodontics Silesian Medical University	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (7)

Abdelnabi MH, Swelem AA. Influence of defective complete dentures renewal on TMD; an MRI and clinical controlled prospective study. Gerodontology. 2015 Sep;32(3):211-21. doi: 10.1111/ger.12102. Epub 2013 Dec 16. — View Citation

Ammanna S, Rodrigues A, Shetty NS, Shetty K, Augustine D, Patil S. A tomographic study of the mandibular condyle position in partially edentulous population. J Contemp Dent Pract. 2015 Jan 1;16(1):68-73. — View Citation

Amorim VC, Laganá DC, de Paula Eduardo JV, Zanetti AL. Analysis of the condyle/fossa relationship before and after prosthetic rehabilitation with maxillary complete denture and mandibular removable partial denture. J Prosthet Dent. 2003 May;89(5):508-14. — View Citation

Huang M, Hu Y, Yu J, Sun J, Ming Y, Zheng L. Cone-beam computed tomographic evaluation of the temporomandibular joint and dental characteristics of patients with Class II subdivision malocclusion and asymmetry. Korean J Orthod. 2017 Sep;47(5):277-288. doi: 10.4041/kjod.2017.47.5.277. Epub 2017 Jul 27. — View Citation

Imanimoghaddam M, Madani AS, Mahdavi P, Bagherpour A, Darijani M, Ebrahimnejad H. Evaluation of condylar positions in patients with temporomandibular disorders: A cone-beam computed tomographic study. Imaging Sci Dent. 2016 Jun;46(2):127-31. doi: 10.5624/isd.2016.46.2.127. Epub 2016 Jun 23. — View Citation

Katzberg RW, Keith DA, Ten Eick WR, Guralnick WC. Internal derangements of the temporomandibular joint: an assessment of condylar position in centric occlusion. J Prosthet Dent. 1983 Feb;49(2):250-4. — View Citation

Wilkie ND, Hurst TL, Mitchell DL. Radiographic comparisons of condyle-fossa relationships during maxillomandibular registrations made by different methods. J Prosthet Dent. 1974 Nov;32(5):529-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mandible condyles centralisation in temporomandibular joints	mandible condylecentral position	1 year
Secondary	Pain intensity changes in Visual Analogue Scale	subjective pain intensity 0-10 points	1 year
Secondary	Anamnestic Index	Evaluation of an anamnestic index according to Helkimo	1 year
Secondary	Dysfunction Index	Evaluation of an dysfunction index	1 year