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Enrolling by invitation NCT07290725

Cross-cultural Adaptation and Translation Validation of the iADH Universal Case Mix Tool (UCMT).

Observational Dentistry

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dentistry. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to translate, culturally adapt, and validate the iADH Universal Case Mix Tool (UCMT) for dental care professionals working with people with disabilities. The study will assess linguistic accuracy, applicability, and reliability/validity of the German, Spanish and Portuguese version of the instrument.

Detailed description

This study is a multicentre, non-interventional methodological study aimed at translating, culturally adapting, and validating the iADH Universal case mix tool (UCMT) for use by dental care professionals working with people living with disabilities, following international guidelines for cross-cultural adaptation of measurement instruments. The translation and cultural adaptation process will include forward and backward translations of the original UCMT (English) to German, Spanish and Portuguese. Two independent forward translations will be performed for each language, followed by reconciliation into a single version, based on semantic equivalence, clarity and cultural appropriateness. Blinded backward translations into English will then be conducted to ensure conceptual consistency with the original instrument. A panel of experts, composed of dental experts and linguistic professionals fluent in both languages will review all translated versions using a Delphi approach. Later, the adapted instruments will be reviewed by the original UCMT developers for the final approval. Consent Validity Index (CVI) of the translated UCMT will be evaluated through expert ratings and cognitive interviews with dental professionals experienced in special care dentistry. Following the experts' validation, a pilot reliability phase will be conducted using standardised online clinical cases developed for the original versions of the UCMT. Participating raters will complete an online questionnaire using the translated UCMT. Intra and interrater agreement will be assessed to evaluate consistency of the translated instrument in a simulated clinical scenario. This study does not involve real patients of the collection of sensitive personal data.

Primary outcome measures

  • Content validity of the translated UCMT [Time frame: 1 week]
Secondary outcome measures (2)
  • Interrater agreement of the UCMT domains scores [Time frame: 1 month]
  • Temporal stability (Test-retest) of UCMT domain scores [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

  • Special care dentist
  • Native in German, Spanish or Portuguese
  • Agree to participate, complete the instrument 2 times

Exclusion criteria

  • Not meeting the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • SFU - Online questionnaire — Vienna

Publications

  • Mac Giolla Phadraig C, Faulks D, McGrath C, Dougall A, Molina G. Development and Content Validity of the International Association for Disability and Oral Health Universal Case Mix Tool: A Consensus Study. Community Dent Oral Epidemiol. 2025 Aug;53(4):402-412. doi: 10.1111/cdoe.13041. Epub 2025 Apr 30. PMID 40304234

Identifiers

NCT: NCT07290725 · 17793138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗