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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Diagnostic test: Hindi version of self reported oral health questionnaire

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: ADITI SANGWAN; Phone Number: 09996002408; Email: aditidalal86@yahoo.co.in
• Study Contact Backup: Name: RINDA SHARMA; Phone Number: 08851499192; Email: rinda.sharma1995@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute O Fdental Sciences
      • Contact: RINDA SHARMA; Phone Number: 08851499192; Email: rinda.sharma1995@gmail.com
      • Contact: Aditi SANGWAN; Phone Number: 09996002408

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population.	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.	1-1.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of responses of Self-Reported Questionnaire for periodontal health with demographic data of the patient	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	1-1.5 months
Correlation of Bleeding on probing (BOP) with response of Self- Reported Questionnaire for periodontal health	Bleeding on probing was checked for each patient and response from their Hindi version self-reported oral health questionnaire were correlated	1-1.5 months
Correlation of Probing pocket depth (PPD) with Self-Reported Questionnaire for periodontal health	Probing pocket depth was measured for each patient and their response of the Hindi version self-reported questionnaire was correlated	1-1.5 months
Correlation of Clinical attachment level (CAL) with Self-Reported Questionnaire for periodontal health	Clinical attachment loss was measured for each patient and their response of the Hindi version of self-reported oral health questionnaire was correlated	1-1.5 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Aditi SANGWAN, Post graduate institute of Dental Sciences ROHTAK; Principal Investigator: RINDA SHARMA, PT. B. D. SHARMA UHSR HARYANA

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: ADITIPERIO(SURVEILLENCE)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No