NCT06784219

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Background- Periodontal disease, with its chronic systemic effects and poor influence on the quality of life of the patient, is global healthcare challenge. Hence there is a for timely diagnosis and treatment of the patients. 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. Expected outcomes- Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population and its ability to predict periodontal status will be evaluated. If found to be valid, this could serve as a vital tool for periodontal health screening for Hindi speaking population at the primary care level.

Conditions

• Periodontitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-02-28
• Completion: 2025-03-15
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: India