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

Not yet recruiting

• Conditions: Periodontitis

• Registration Number: NCT06784219
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study Start: 2025-01-15
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Individuals aged 18 or above and voluntarily agreeing to participate in the study.

Exclusion Criteria

• Edentulous adults Pregnant females Individuals having received antibiotic medication within the previous 3 months Individuals having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population.	1-1.5 months	Hindi version of self-reported oral health questionnaire will be administered to consecutive patients attending out-patient department. Periodontal status of the patients was then evaluated by measuring PI, GI, PPD, BOP, CAL. Their responses were then correlated with the periodontal status.

Secondary Outcome Measures

Name	Time	Method
Correlation of responses of Self-Reported Questionnaire for periodontal health with demographic data of the patient	1-1.5 months	The responses will be evaluated along with demographic data of the patient like age, gender, level of education, occupation, marital status and place of residence
Correlation of Bleeding on probing (BOP) with response of Self- Reported Questionnaire for periodontal health	1-1.5 months	Bleeding on probing was checked for each patient and response from their Hindi version self-reported oral health questionnaire were correlated
Correlation of Probing pocket depth (PPD) with Self-Reported Questionnaire for periodontal health	1-1.5 months	Probing pocket depth was measured for each patient and their response of the Hindi version self-reported questionnaire was correlated
Correlation of Clinical attachment level (CAL) with Self-Reported Questionnaire for periodontal health	1-1.5 months	Clinical attachment loss was measured for each patient and their response of the Hindi version of self-reported oral health questionnaire was correlated

Trial Locations

Locations (1)

Post Graduate Institute O Fdental Sciences; 🇮🇳 Rohtak, Haryana, India