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Temporomandibular DisordersNCT03343015

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

An observational study of Temporomandibular Disorders, run by Medical University of Silesia at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorders
What is being tested?
complete dentures
Type of treatment
Surgery or procedure
How many people
72 participants
Where
1 sitePoland
Study dates
24 Feb 2014to 20 Feb 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Department of TMD and Orthodontics Silesian Medical University

    Zabrze, 41-800

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
complete dentures
Keywords
TMD, centric relation, complete dentures
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • complete denturesProcedure or surgery

    therapy with maxilla and mandible dentures

Study groups in NCT03343015
Study groupRoleWhat they receive
Traditional CR establishingestablishing a CR in traditional way with occlusal wax rims during complete dentures therapy
Receives: Procedure: complete dentures
Gothic arch methodestablishing a CR with gothic arch tracing device during complete dentures therapy
Receives: Procedure: complete dentures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mandible condyles centralisation in temporomandibular joints

    mandible condylecentral position

    Measured: 1 year

Secondary outcomes (3)

  1. Pain intensity changes in Visual Analogue Scale

    subjective pain intensity 0-10 points

    Measured: 1 year

  2. Anamnestic Index

    Evaluation of an anamnestic index according to Helkimo

    Measured: 1 year

  3. Dysfunction Index

    Evaluation of an dysfunction index

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start24 Feb 2014
  3. Primary completion20 Feb 2016
  4. Study completion20 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03343015
Sponsor's protocol ID
Mandible centralisation
Status last verified
Jun 2019
First submitted
31 Oct 2017
Last updated
25 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27358820

  • 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. doi: 10.5005/jp-journals-10024-1637.

    PubMed 25876953

  • Amorim VC, Lagana 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. doi: 10.1016/s0022-3913(03)00029-5.

    PubMed 12806330

  • 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.

    PubMed 24341614

  • 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.

    PubMed 28861389

  • 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. doi: 10.1016/0022-3913(74)90007-9. No abstract available.

    PubMed 4531485

  • 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. doi: 10.1016/0022-3913(83)90511-5.

    PubMed 6572265

  • 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.

    PubMed 29623141

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Disorders, run by Medical University of Silesia at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mandible condyles centralisation in temporomandibular joints (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03343015, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.

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