Clinical trial NCT06784219: Development and Validation of Self-Reported Surveillance Questionnaire of Periodontal Health in Indian Population
Official title: Development and Validation of Self-Reported Surveillance Questionnaire of Periodontal Health in Indian Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Periodontitis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study has been designed as a cross-sectional study based on a convenience sample of consecutive patients seeking dental care at the Post Graduate Institute of Dental Sciences (PGIDS), Rohtak. The participants will comprise of individuals aged 18 or above and voluntarily agreeing to participate in the study. The exclusion criteria are: 1) edentulous adults, 2) pregnant females, 3) individuals having received antibiotic medication within the previous 3 months, 4) individuals having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months. Informed consent will be obtained from each participant prior to enrolment in the study.

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.

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.

Primary outcomes:
measure: Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population.
timeFrame: 1-1.5 months
Secondary outcomes:
measure: Correlation of responses of Self-Reported Questionnaire for periodontal health with demographic data of the patient
timeFrame: 1-1.5 months
measure: Correlation of Bleeding on probing (BOP) with response of Self- Reported Questionnaire for periodontal health
timeFrame: 1-1.5 months
measure: Correlation of Probing pocket depth (PPD) with Self-Reported Questionnaire for periodontal health
timeFrame: 1-1.5 months
measure: Correlation of Clinical attachment level (CAL) with Self-Reported Questionnaire for periodontal health
timeFrame: 1-1.5 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute O Fdental Sciences
state: Haryana
Study officials:
affiliation: Post graduate institute of Dental Sciences ROHTAK
name: Aditi SANGWAN
role: PRINCIPAL_INVESTIGATOR
affiliation: PT. B. D. SHARMA UHSR HARYANA
name: RINDA SHARMA
role: PRINCIPAL_INVESTIGATOR
References: