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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06784219
Enrollment
200
Registered
2025-01-20
Start date
2025-01-15
Completion date
2025-03-15
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

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.

Interventions

DIAGNOSTIC_TESTHindi 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.

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population.1-1.5 monthsHindi 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

MeasureTime frameDescription
Correlation of responses of Self-Reported Questionnaire for periodontal health with demographic data of the patient1-1.5 monthsThe responses will be evaluated along with demographic data of the patient like age, gender, level of education, occupation, marital status and place of residence
Correlation of Bleeding on probing (BOP) with response of Self- Reported Questionnaire for periodontal health1-1.5 monthsBleeding on probing was checked for each patient and response from their Hindi version self-reported oral health questionnaire were correlated
Correlation of Probing pocket depth (PPD) with Self-Reported Questionnaire for periodontal health1-1.5 monthsProbing pocket depth was measured for each patient and their response of the Hindi version self-reported questionnaire was correlated
Correlation of Clinical attachment level (CAL) with Self-Reported Questionnaire for periodontal health1-1.5 monthsClinical attachment loss was measured for each patient and their response of the Hindi version of self-reported oral health questionnaire was correlated

Countries

India

Contacts

Primary ContactADITI SANGWAN
aditidalal86@yahoo.co.in09996002408
Backup ContactRINDA SHARMA
rinda.sharma1995@gmail.com08851499192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026