DentistryCCV UCMTNCT07290725
Cross-cultural Adaptation and Translation Validation of the iADH Universal Case Mix Tool (UCMT).
An observational study of Dentistry, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dentistry
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion Criteria: * Special care dentist * Native in German, Spanish or Portuguese * Agree to participate, complete the instrument 2 times
Who may be able to join
- Special care dentist
- Native in German, Spanish or Portuguese
- Agree to participate, complete the instrument 2 times
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Dentistry
- Keywords
- special care dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| special care dentists - spanish | Special Care Dentistry Specialist, native Spanish speaker | |
| Special care dentists - german | Special Care Dentistry Specialist, native German speaker | |
| Special care dentists - Portuguese | Special Care Dentistry Specialist, native Portuguese speaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content validity of the translated UCMT
Content validity of the UCMT will be assessed by a panel of multidisciplinary experts, assessing clarity, relevance and cultural appropriateness. Experts ratings will be used to calculate Content Validity Index (CVI) for the translated versions of the UCMT. Unit of measure: CVI (Range 0-1)
Measured: 1 week
Secondary outcomes (2)
Interrater agreement of the UCMT domains scores
Interrater agreement will be assessed based on scores assigned to the seven domains of the UCMT in the original version and validation. Raters will independently evaluate standardised online cases using the translated versions of the UCMT. Agreement between raters will be quantified for each UCMT domain.
Unit of measure:
Interclass correlation coefficient (range 0-1)
Measured: 1 month
Temporal stability (Test-retest) of UCMT domain scores
Intrarater agreement (Temporal stability) will be assessed based on scores assigned to the seven domains of the UCMT in the original version and validation. Raters will independently evaluate standardised online cases using the translated versions of the UCMT on two occasions separated by 1-2 weeks . Agreement between these occasions will be quantified for each UCMT domain.
Unit of measure:
Interclass correlation coefficient (range 0-1)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Nov 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DentistryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg, University of Chile
- Responsible party
- Principal investigator, Sebastian Veliz, Sigmund Freud PrivatUniversitat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290725
- Sponsor's protocol ID
- 17793138
- Acronym
- CCV UCMT
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not necessary
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.
PubMed 40304234
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Translation Validation of the iADH Universal Case Mix Tool (UCMT).
- ClinicalTrials.gov ID
- NCT07290725
- Acronym / sponsor ID
- CCV UCMT / 17793138
- Conditions
- Dentistry
- Keywords
- special care dentistry
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sigmund Freud PrivatUniversitatUniversity, hospital or other
- Collaborators
- University of Freiburg, University of Chile
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| special care dentists - spanish | – | –Special Care Dentistry Specialist, native Spanish speaker |
| Special care dentists - german | – | –Special Care Dentistry Specialist, native German speaker |
| Special care dentists - Portuguese | – | –Special Care Dentistry Specialist, native Portuguese speaker |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion Criteria: * Special care dentist * Native in German, Spanish or Portuguese * Agree to participate, complete the instrument 2 times
Key inclusion criteria (3 listed)
- Special care dentist
- Native in German, Spanish or Portuguese
- Agree to participate, complete the instrument 2 times
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Content validity of the translated UCMT
Time frame: 1 week
Content validity of the UCMT will be assessed by a panel of multidisciplinary experts, assessing clarity, relevance and cultural appropriateness. Experts ratings will be used to calculate Content Validity Index (CVI) for the translated versions of the UCMT. Unit of measure: CVI (Range 0-1)
2 secondary outcomes
Interrater agreement of the UCMT domains scores
Time frame: 1 month
Temporal stability (Test-retest) of UCMT domain scores
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 40304234Mac 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.
- Individual participant dataSharing planned: No. Not necessary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentistry, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
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 1 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
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?
Content validity of the translated UCMT (time frame: 1 week). 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 NCT07290725, which also lists 1 linked publication.
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 30 Mar 2026.