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NOT YET RECRUITING
NCT06784219

Development and Validation of Self-Reported Surveillance Questionnaire of Periodontal Health in Indian Population

Sponsor: Postgraduate Institute of Dental Sciences Rohtak

View on ClinicalTrials.gov

Summary

Rationale- Periodontal disease is a dynamic inflammatory condition, that affects the periodontium and has a profound effect on the overall systemic health of the individual. Unfortunately, the symptoms of periodontal disease often go unnoticed by affected individuals and this contributes towards unpleasant and irreversible consequences such as tooth loss. Hence it is important to develop an easy, cost effective and widely acceptable method for the patients to assess their periodontal health. Objectives- To translate, culturally adapt and validate the CDC/AAP questionnaire along with other relevant surveillance questions in the Hindi language according to the new case definitions of periodontal diseases. Methods- The original 8-item CDC/AAP questionnaire as well as other selected periodontal disease surveillance questions will be translated into Hindi through forward translation, backward translation, and expert committee process to reach a consensus and produce a final version. The final version of the questionnaire will be administered to patients seeking care from out-patient department of department of Periodontics at PGIDS, Rohtak. Full-mouth periodontal examination, consisting of measurements of the probing pocket depth (PPD), full mouth bleeding score (FMBS) and clinical attachment level (CAL) at six sites per tooth using periodontal probe will be carried out for each participant.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-01-15

Completion Date

2025-03-15

Last Updated

2025-01-20

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Hindi version of self reported oral health questionnaire

The original 8-item CDC/AAP questionnaire as well as other selected periodontal disease surveillance questions will be translated into Hindi through forward translation, backward translation, and expert committee process to reach a consensus and produce a prefinal version. The prefinal version questionnaire will be pilot tested on a sample of 20 patients to evaluate the overall comprehension by non-professionals. On the basis of responses and evaluation from the participants, the questionnaire will be further refined to build the final version. The final version of the questionnaire will be administered to patients seeking care from out-patient department of department of Periodontics at PGIDS, Rohtak. The participants will be required to fill the questionnaire by themselves prior to periodontal examination, without any help from others.

Locations (1)

Post Graduate Institute O Fdental Sciences

Rohtak, Haryana, India