An observational study in Edentulism, sponsored by St. Petersburg State Pavlov Medical University. Not yet recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by St. Petersburg State Pavlov Medical University · Observational
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.
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.
St. Petersburg State Pavlov Medical University is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline questionnaire assessment in the main psychometric sample; anticipated February-September 2027.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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St. Petersburg State Pavlov Medical University