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Not Yet Recruiting NCT07904117

Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss

Conditions: Edentulism

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 330
Sponsor: St. Petersburg State Pavlov Medical University

Location: Saint Petersburg City Dental Clinic No. 33 Saint Petersburg Sankt-Peterburg

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 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07904117). StuddyBuddy aggregates publicly available trial information.