- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07303491
Validation of Hindi Version Oral Health Impact Profile for Periodontitis
May 22, 2026 updated by: Postgraduate Institute of Dental Sciences Rohtak
Translation and Validation of Hindi Version of Oral Health Impact Profile for Chronic Periodontitis (OHIP-CP) a Condition Specific Tool to Assess Oral Health Related Quality of Life in Patients With Chronic Periodontitis
Translation of OHIP-CP questionnaire in Hindi language will be done.
Patients recruited will undergo clinical examination and recording of periodontal parameters (Pocket probing Depth and Clinical Attachment Loss) will be recorded to determine stage and grade of periodontitis.
Patients will be given OHIP-CP Hindi questionnaire.
Content Validity and Construct validity of Hindi translated OHIP-CP questionnaire will be done using appropriate statistical measures.
Reliability of the OHIP-CP Hindi questionnaire will be checked for Internal consistency using Cronbach alpha for whole and subscales of OHIP-CP.
Study Overview
Study Type
Observational
Enrollment (Actual)
196
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haryana
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Rohtak, Haryana, India, 124001
- PGIDS Rohtak
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with periodontitis
Description
Inclusion Criteria:
- ≥18 years of age
- able to understand and complete questionnaires independently
- confirmed diagnosis of periodontitis as defined by the 2017 World Workshop classification.
Exclusion Criteria:
- Patients with systemic diseases such as acquired immunodeficiency syndrome or diabetes mellitus,
- pregnancy
- patients who require prophylactic antibiotic coverage prior to dental treatment,
- patients with bleeding disorders,
- patients had received non-surgical periodontal therapy within the preceding eight weeks.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliability Analysis
Time Frame: Baseline
|
Internal consistency of the scale will be evaluated using Cronbach's alpha
|
Baseline
|
|
Construct validity
Time Frame: Baseline
|
Construct validity of the scale was first evaluated through exploratory factor analysis (EFA) for KMO, Bartlett's test of sphericity and total variance. Followed by confirmatory factor analysis (CFA) for factor loadings |
Baseline
|
|
Discriminant validity
Time Frame: Baseline
|
Discriminative validity of the scale will be assessed by comparing mean score by Kruskal-Wallis H test for differences across varying stages of periodontitis.
|
Baseline
|
|
Convergent validity
Time Frame: Baseline
|
Convergent validity will be evaluated by examining spearman's rho correlation with the global oral health ratings
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2025
Primary Completion (Actual)
January 30, 2026
Study Completion (Actual)
February 20, 2026
Study Registration Dates
First Submitted
November 29, 2025
First Submitted That Met QC Criteria
December 10, 2025
First Posted (Actual)
December 24, 2025
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 22, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGIDS/BHRC/25/61
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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