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NCT Number: NCT06784219

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population.

    Time frame: 1-1.5 months

    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.

Secondary outcomes

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

    Time frame: 1-1.5 months

    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

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

    Time frame: 1-1.5 months

    Bleeding on probing was checked for each patient and response from their Hindi version self-reported oral health questionnaire were correlated

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

    Time frame: 1-1.5 months

    Probing pocket depth was measured for each patient and their response of the Hindi version self-reported questionnaire was correlated

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

    Time frame: 1-1.5 months

    Clinical attachment loss was measured for each patient and their response of the Hindi version of self-reported oral health questionnaire was correlated

Study contacts

Contact information is provided by the study sponsor or research team.

ADITI SANGWAN

CONTACT

[email protected]

09996002408

RINDA SHARMA

CONTACT

[email protected]

08851499192

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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