Oral HealthNCT05751902
Translation and Validation of the Arabic Version of the OHIP Questionnaire
An observational study of Oral Health and Surveys and Questionnaires, run by Future University in Egypt at 2 sites in Egypt.
Trial summary
OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Surveys and Questionnaires
- What is being tested?
- Arabic version of OHIP questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 254 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Dec 2022to 30 Jan 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: any participant fluent in Arabic language and having a removable prosthesis.
Who may be able to join
- Patients having removable partial denture in the last year
- Native Arabic patients
Who cannot join
- Patients non familiar with Arabic language
- patients with mental or perception problems
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Future University in Egypt
Cairo, 111111
Medhat Abdelaziz, MSc., 01094023661, dr.medhatsameh@gmail.com
- Recruiting
Future University in Egypt
Cairo
Medhat Abdelaziz, M.S.C, 00201094023661, medhat.abdelaziz@fue.edu.eg
About this study
Official title: Translation and Validation of the Arabic Version of the Oral Health Impact Profile Questionnaire
OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. As people living in middle east are mainly influenced by the Arabic culture, which differs significantly from the Western culture where the OHIP questionnaire was first developed.
254 participants having removable prosthesis will be asked to complete translated Arabic version of OHIP questionnaire for validation.
- Conditions
- Oral Health, Surveys and Questionnaires
- Being tested
- Arabic version of OHIP questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic version of OHIP questionnaireOther
Translated Arabic version of Oral Health Impact Profile questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability and validity
Reliability of Translated Arabic version of OHIP questionnaire using internal consistency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start15 Dec 2022
- Primary completion28 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Sameh Abdelaziz, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751902
- Sponsor's protocol ID
- FUE.REC (1)/1-2023
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Arabic Version of the Oral Health Impact Profile Questionnaire
- ClinicalTrials.gov ID
- NCT05751902
- Acronym / sponsor ID
- FUE.REC (1)/1-2023
- Conditions
- Oral Health, Surveys and Questionnaires
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 28 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. As people living in middle east are mainly influenced by the Arabic culture, which differs significantly from the Western culture where the OHIP questionnaire was first developed.
254 participants having removable prosthesis will be asked to complete translated Arabic version of OHIP questionnaire for validation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- any participant fluent in Arabic language and having a removable prosthesis.
Key inclusion criteria (2 listed)
- Patients having removable partial denture in the last year
- Native Arabic patients
Key exclusion criteria (2 listed)
- Patients non familiar with Arabic language
- patients with mental or perception problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabic version of OHIP questionnaireTranslated Arabic version of Oral Health Impact Profile questionnaire | Other | – |
Primary outcome
Reliability and validity
Time frame: 3 months
Reliability of Translated Arabic version of OHIP questionnaire using internal consistency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health and Surveys and Questionnaires, run by Future University in Egypt at 2 sites in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and validity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.