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

Overview

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.

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 w

Primary outcome measures

• Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population. [Time frame: 1-1.5 months]

Secondary outcome measures (4)

• Correlation of responses of Self-Reported Questionnaire for periodontal health with demographic data of the patient [Time frame: 1-1.5 months]
• Correlation of Bleeding on probing (BOP) with response of Self- Reported Questionnaire for periodontal health [Time frame: 1-1.5 months]
• Correlation of Probing pocket depth (PPD) with Self-Reported Questionnaire for periodontal health [Time frame: 1-1.5 months]
• Correlation of Clinical attachment level (CAL) with Self-Reported Questionnaire for periodontal health [Time frame: 1-1.5 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Ecologic or community

Study locations

India · 1 center

• Post Graduate Institute O Fdental Sciences — Rohtak

Identifiers

NCT: NCT06784219 · ADITIPERIO(SURVEILLENCE)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗