EdentulismOHIP-EDENT-RUNCT07904117
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
An observational study of Edentulism, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
The Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19) is a 19-question survey about how complete tooth loss and dentures affect daily life. This study will translate and culturally adapt the questionnaire into Russian and assess its validity and reliability in Russian-speaking adults who have lost all… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulism
- How many people
- 330 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2026to 31 Oct 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult, Russian-speaking outpatients attending the prosthodontic department of Saint Petersburg City Dental Clinic No. 33 who meet the eligibility criteria. The study includes up to 30 participants in cognitive interviews and 300 participants in the main psychometric sample.
Who may be able to join
- Age 18 years or older.
- Complete tooth loss in both the upper and lower jaws.
- Current use of complete removable dentures for both jaws, including patients seeking new dentures or replacement of existing dentures.
- Sufficient Russian-language proficiency to understand the questionnaire and response options independently.
- Ability to provide informed consent and signed informed consent.
Who cannot join
- Any remaining natural tooth or retained tooth root in either jaw.
- Complete tooth loss in only one jaw with natural teeth present in the other jaw.
- No complete removable denture for either jaw at the time of questionnaire administration.
- A condition that prevents informed decision-making or reliable understanding of the questionnaire.
- An acute condition requiring urgent medical care.
- Refusal to participate or withdrawal of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Saint Petersburg City Dental Clinic No. 33
Saint Petersburg, Sankt-Peterburg, 197341
Study Information Contact, +7 (812) 301-80-59, pstom33@zdrav.spb.ru
Roman A Rozov, MD, DSc
About this study
Official title: Translation, Cross-Cultural Adaptation, and Psychometric Validation of the Russian Version of the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19)
The Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19) is a 19-question survey about how complete tooth loss and dentures affect daily life. This study will translate and culturally adapt the questionnaire into Russian and assess its validity and reliability in Russian-speaking adults who have lost all teeth in both jaws and wear complete removable dentures. The study includes cognitive interviews with up to 30 participants and a psychometric assessment in 300 participants. A subgroup of 60-80 clinically stable participants will complete the questionnaire again after 10-14 days. No treatment is assigned or changed; participation involves questionnaires, interviews, and collection of limited demographic and clinical information.
Read the detailed description
This single-center, non-interventional methodological study will develop and evaluate a Russian-language version of the 19-item Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19). The study has two parts: translation and cross-cultural adaptation, followed by psychometric evaluation.
Translation and adaptation: two independent English-to-Russian translations will be reconciled, followed by independent back-translation and expert review. The pre-final version will undergo cognitive interviews with up to 30 members of the target population to assess comprehension, interpretation, and acceptability. Wording may be revised and retested as needed before the final version is fixed.
Psychometric evaluation: 300 adults with complete tooth loss in both jaws who use complete removable dentures will complete the final Russian questionnaire and provide demographic and limited clinical information. Confirmatory factor analysis will assess prespecified one-, three-, and seven-factor models. Internal consistency will be evaluated with Cronbach alpha and McDonald omega. Construct validity will be assessed using prespecified hypotheses about associations with denture satisfaction, global oral-health self-rating, and known groups based on the routine clinical indication for denture replacement. Response distributions, missing responses, and floor and ceiling effects will also be described.
Test-retest reliability: 60-80 clinically stable participants from the main psychometric sample will complete the questionnaire again 10-14 days after the first administration. Reliability will be assessed using the intraclass correlation coefficient for absolute agreement, with measurement error estimates. Participants whose oral or denture status changes during the interval will not contribute to the primary test-retest analysis.
The study does not assign a treatment, change routine care, or require additional invasive procedures.
- Conditions
- Edentulism
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural Validity of OHIP-EDENT-RU Assessed by Confirmatory Factor Analysis
Fit of the prespecified one-, three-, and seven-factor models assessed using CFI, TLI, RMSEA, and SRMR, with standardized factor loadings and inter-factor correlations.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Secondary outcomes (8)
Internal Consistency of OHIP-EDENT-RU
Cronbach alpha, McDonald omega, 95% confidence intervals, and corrected item-total correlations for the total score and supported subscales.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Test-Retest Reliability and Measurement Error
Absolute-agreement intraclass correlation coefficients with 95% confidence intervals, standard error of measurement (SEM), and smallest detectable change (SDC95) among 60-80 clinically stable participants.
Measured: Repeat questionnaire 10-14 days after baseline; anticipated February-October 2027.
Construct Validity of OHIP-EDENT-RU
Spearman correlations with denture-satisfaction VAS and global oral-health self-rating, and comparison of participants with versus without a routine clinical indication for denture replacement.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Item Response Distributions of OHIP-EDENT-RU
For each of the 19 OHIP-EDENT-RU items, the percentage of non-missing responses in each response category will be reported. Unit of measure: percentage.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Total-Score Distribution of OHIP-EDENT-RU
Distribution of OHIP-EDENT-RU total scores in the main psychometric sample. Unit of measure: OHIP-EDENT-RU total-score points.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Missing Item Responses of OHIP-EDENT-RU
For each of the 19 OHIP-EDENT-RU items, the percentage of participants with a missing response will be reported, using all participants assessed in the main psychometric sample as the denominator. Unit of measure: percentage.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Floor Effect of the OHIP-EDENT-RU Total Score
Percentage of participants with the minimum possible OHIP-EDENT-RU total score among participants with a calculable total score in the main psychometric sample. Unit of measure: percentage.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Ceiling Effect of the OHIP-EDENT-RU Total Score
Percentage of participants with the maximum possible OHIP-EDENT-RU total score among participants with a calculable total score in the main psychometric sample. Unit of measure: percentage.
Measured: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman A Rozov, MD, DSc, Principal investigator, Pavlov First Saint Petersburg State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904117
- Sponsor's protocol ID
- OHIP-EDENT-RU
- Acronym
- OHIP-EDENT-RU
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol does not include a plan to share individual participant data with external researchers. De-identified data may be shared within the research team for statistical analysis; study results will be published in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-Cultural Adaptation, and Psychometric Validation of the Russian Version of the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19)
- ClinicalTrials.gov ID
- NCT07904117
- Acronym / sponsor ID
- OHIP-EDENT-RU / OHIP-EDENT-RU
- Conditions
- Edentulism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Oct 2026 (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.
The Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19) is a 19-question survey about how complete tooth loss and dentures affect daily life. This study will translate and culturally adapt the questionnaire into Russian and assess its validity and reliability in Russian-speaking adults who have lost all teeth in both jaws and wear complete removable dentures. The study includes cognitive interviews with up to 30 participants and a psychometric assessment in 300 participants. A subgroup of 60-80 clinically stable participants will complete the questionnaire again after 10-14 days. No treatment is assigned or changed; participation involves questionnaires, interviews, and collection of limited demographic and clinical information.
Detailed description
This single-center, non-interventional methodological study will develop and evaluate a Russian-language version of the 19-item Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-19). The study has two parts: translation and cross-cultural adaptation, followed by psychometric evaluation.
Translation and adaptation: two independent English-to-Russian translations will be reconciled, followed by independent back-translation and expert review. The pre-final version will undergo cognitive interviews with up to 30 members of the target population to assess comprehension, interpretation, and acceptability. Wording may be revised and retested as needed before the final version is fixed.
Psychometric evaluation: 300 adults with complete tooth loss in both jaws who use complete removable dentures will complete the final Russian questionnaire and provide demographic and limited clinical information. Confirmatory factor analysis will assess prespecified one-, three-, and seven-factor models. Internal consistency will be evaluated with Cronbach alpha and McDonald omega. Construct validity will be assessed using prespecified hypotheses about associations with denture satisfaction, global oral-health self-rating, and known groups based on the routine clinical indication for denture replacement. Response distributions, missing responses, and floor and ceiling effects will also be described.
Test-retest reliability: 60-80 clinically stable participants from the main psychometric sample will complete the questionnaire again 10-14 days after the first administration. Reliability will be assessed using the intraclass correlation coefficient for absolute agreement, with measurement error estimates. Participants whose oral or denture status changes during the interval will not contribute to the primary test-retest analysis.
The study does not assign a treatment, change routine care, or require additional invasive procedures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult, Russian-speaking outpatients attending the prosthodontic department of Saint Petersburg City Dental Clinic No. 33 who meet the eligibility criteria. The study includes up to 30 participants in cognitive interviews and 300 participants in the main psychometric sample.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Complete tooth loss in both the upper and lower jaws.
- Current use of complete removable dentures for both jaws, including patients seeking new dentures or replacement of existing dentures.
- Sufficient Russian-language proficiency to understand the questionnaire and response options independently.
- Ability to provide informed consent and signed informed consent.
Key exclusion criteria (6 listed)
- Any remaining natural tooth or retained tooth root in either jaw.
- Complete tooth loss in only one jaw with natural teeth present in the other jaw.
- No complete removable denture for either jaw at the time of questionnaire administration.
- A condition that prevents informed decision-making or reliable understanding of the questionnaire.
- An acute condition requiring urgent medical care.
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
Structural Validity of OHIP-EDENT-RU Assessed by Confirmatory Factor Analysis
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Fit of the prespecified one-, three-, and seven-factor models assessed using CFI, TLI, RMSEA, and SRMR, with standardized factor loadings and inter-factor correlations.
8 secondary outcomes
Internal Consistency of OHIP-EDENT-RU
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Test-Retest Reliability and Measurement Error
Time frame: Repeat questionnaire 10-14 days after baseline; anticipated February-October 2027.
Construct Validity of OHIP-EDENT-RU
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Item Response Distributions of OHIP-EDENT-RU
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Total-Score Distribution of OHIP-EDENT-RU
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Missing Item Responses of OHIP-EDENT-RU
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Floor Effect of the OHIP-EDENT-RU Total Score
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Ceiling Effect of the OHIP-EDENT-RU Total Score
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
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 29 Oct 2026.
- Individual participant dataSharing planned: No. The protocol does not include a plan to share individual participant data with external researchers. De-identified data may be shared within the research team for statistical analysis; study results will be published in aggregate form.
Related trials for Edentulism
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
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.
Saint Petersburg City Dental Clinic No. 33
Saint Petersburg, Russia
Roman A Rozov, MD, DSc principal investigator
Pavlov First Saint Petersburg State Medical University
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 Edentulism, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Oct 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 Russia. 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?
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?
Structural Validity of OHIP-EDENT-RU Assessed by Confirmatory Factor Analysis (time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.). 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 29 Oct 2026.