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临床试验/NCT06784219
NCT06784219尚未招募不适用

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

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Response to self- reported questionnaire (individual questions as well as in combination) in Hindi speaking population.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjay Tewari

Principal

Postgraduate Institute of Dental Sciences Rohtak

研究点 (1)

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