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

NCT06784219 | Not Yet Recruiting

• 1 other identifier: ADITIPERIO(SURVEILLENCE)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation of responses of Self-Reported Questionnaire for periodontal health with demographic data of the patient

  1-1.5 months

• Correlation of Bleeding on probing (BOP) with response of Self- Reported Questionnaire for periodontal health

  1-1.5 months

• Correlation of Probing pocket depth (PPD) with Self-Reported Questionnaire for periodontal health

  1-1.5 months

• Correlation of Clinical attachment level (CAL) with Self-Reported Questionnaire for periodontal health

  1-1.5 months

Study Arms (1)

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

Interventions

Hindi version of self reported oral health questionnaire 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.

Consecutive patients seeking dental care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute O Fdental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Aditi SANGWAN

  Post graduate institute of Dental Sciences ROHTAK

  PRINCIPAL INVESTIGATOR

• RINDA SHARMA

  PT. B. D. SHARMA UHSR HARYANA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ADITI SANGWAN

CONTACT

09996002408; aditidalal86@yahoo.co.in

RINDA SHARMA

CONTACT

08851499192; rinda.sharma1995@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 15, 2025
• Primary Completion: February 28, 2025
• Study Completion: March 15, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

IN (1)