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

NCT ID: NCT06784219

Last Updated: 2025-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-03-15

Brief Summary

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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

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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

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Periodontitis

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Consecutive patients seeking dental care

A cross-sectional study based on a convenience sample of consecutive patients seeking dental care at the Post Graduate Institute of Dental Sciences, Rohtak. The participants will comprise of individuals aged 18 or above. 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 within the previous 12 months.

Hindi version of self reported oral health questionnaire

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Tewari

Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aditi SANGWAN

Role: PRINCIPAL_INVESTIGATOR

Post graduate institute of Dental Sciences ROHTAK

RINDA SHARMA

Role: PRINCIPAL_INVESTIGATOR

PT. B. D. SHARMA UHSR HARYANA

Locations

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Post Graduate Institute O Fdental Sciences

Rohtak, Haryana, India

Site Status

Countries

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India

Central Contacts

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ADITI SANGWAN

Role: CONTACT

09996002408

RINDA SHARMA

Role: CONTACT

08851499192

Facility Contacts

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Aditi SANGWAN

Role: primary

09996002408

RINDA SHARMA

Role: backup

08851499192

Other Identifiers

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ADITIPERIO(SURVEILLENCE)

Identifier Type: -

Identifier Source: org_study_id

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