DC/TMD Axis I for Children

NCT04256811 | Completed DMC

• 1 other identifier: 94-584
• Study Type: observational
• Target: 189
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present investigation was to perform the content and construct validation of the diagnostic criteria for TMD (DC/TMD) Axis I, for children 7 to 11 years old. A Delphi process was used to perfom the content validity of the DC/TMD Axis I. 189 7-11 years old children were assessed with the adapted instrument. Confirmatory factor analysis (CFA) was used to investigate construct validity of the DC/TMD for children. A baseline one-factor model was compared against a two-factor (Model 2) and a seven-factor (Model 3) models based on the original DC/TMD. Root-mean-squared error of approximation (RMSEA), comparative fit index (CFI), chi-square, change in chi-square and Cronbach's Alpha were used to analyze the data. All analysis were performed in STATA© version 13.0.

Conditions

Temporomandibular Disorder; Children, Only; Pain Disorder; Joint Disorder, Temporomandibular

Outcome Measures

Primary Outcomes (3)

• Confirmatory Factor Analysis RMSEA

  Root-mean-squared error of approximation (RMSEA) as a fit index for the factor models.

  Two weeks

• Confirmatory Factor Analysis CFI

  Comparative fit index (CFI) as a fit index for the factor models.

  Two weeks

• Confirmatory Factor Analysis chi-square and change in chi-square

  chi-square and change in chi-square as fit indeces for the factor models

  Two weeks

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 7 and 11 years of age of both genders, that were recruited in the specialized orofacial pain clinic at Universidad CES.

You may qualify if:

• \- Children otherwise healthy (with and without temporomandibular disorders) were included.

You may not qualify if:

• Cleft lip and palate reported by parents and verified its presence and/or sequels by the investigators in the clinical examination.
• Cervical spine malformation.
• Syndromes affecting morphology or facial function.
• Joint diseases.
• Neurological diseases.
• Neuropathies.
• Current or previous treatment of head and neck radiation.
• Fibromyalgia.
• Maxillofacial surgeries.

Sponsors & Collaborators

• CES University: lead

Related Publications (1)

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Somatoform Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Mental Disorders

Study Officials

• Claudia Cecilia Restrepo Serna, PhD

  CES University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: May 19, 2015
• Primary Completion: May 27, 2016
• Study Completion: December 15, 2016
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the article.
• Access Criteria: By requirement to the e-mail crestrepos@ces.edu.co