NCT03343015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

October 31, 2017

Last Update Submit

June 21, 2019

Conditions

Keywords

TMD, centric relation, complete dentures

Outcome Measures

Primary Outcomes (1)

  • Mandible condyles centralisation in temporomandibular joints

    mandible condylecentral position

    1 year

Secondary Outcomes (3)

  • Pain intensity changes in Visual Analogue Scale

    1 year

  • Anamnestic Index

    1 year

  • Dysfunction Index

    1 year

Study Arms (2)

Traditional CR establishing

establishing a CR in traditional way with occlusal wax rims during complete dentures therapy

Procedure: complete dentures

Gothic arch method

establishing a CR with gothic arch tracing device during complete dentures therapy

Procedure: complete dentures

Interventions

therapy with maxilla and mandible dentures

Gothic arch methodTraditional CR establishing

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of TMD and Orthodontics Silesian Medical University

Zabrze, 41-800, Poland

Location

Related Publications (8)

  • 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.

    PMID: 27358820BACKGROUND
  • 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.

    PMID: 25876953BACKGROUND
  • 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.

    PMID: 12806330BACKGROUND
  • 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.

    PMID: 24341614BACKGROUND
  • 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.

    PMID: 28861389BACKGROUND
  • 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.

    PMID: 4531485BACKGROUND
  • 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.

    PMID: 6572265BACKGROUND
  • 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.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Denture, Complete

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Stefan Baron, Profesor

    Department of Temporomandibular Disorders and Orthodontics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator DMD PhD

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 17, 2017

Study Start

February 24, 2014

Primary Completion

February 20, 2016

Study Completion

February 20, 2017

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations