Responsiveness of Hindi Version of Oral Health Impact Profile for Periodontitis (OHIP-P-HIN)

Evaluation of Responsiveness of Hindi Version of Oral Health Impact Profile for Periodontitis (OHIP-P-HIN)

The distribution- and anchor-based methods will be used to estimate the Minimal Important Difference (MID) of the OHIP-P-HIN. Two established distribution-based approaches, the standardized effect size (ES) and standardized response mean (SRM) will be calculated. The ES is calculated by dividing the mean change scores in the OHIP-P-HIN from baseline by the standard deviation of the baseline scores. And the SRM are computed as ratios of the mean change score divided by its standard deviation. The anchor-based approach will be applied by using the global transition scale as the anchor.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

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

    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • PGIDS Rohtak
        • Contact:

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

Description

Inclusion Criteria:

  • ≥18 years of age
  • patients able to understand and complete questionnaires independently
  • confirmed diagnosis of periodontitis

Exclusion Criteria:

  • Patients with systemic diseases such as acquired immunodeficiency syndrome or diabetes mellitus
  • pregnancy
  • required prophylactic antibiotic coverage prior to dental treatment,
  • patients with bleeding disorders
  • patients who 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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non Surgical Periodontal Therapy
Full mouth Sub gingival instrumentation will be done
Full mouth subgingival instrumentation will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Important Difference (MID)
Time Frame: 6 weeks after completion of Non surgical Periodontal therapy
The distribution- and anchor-based methods will be used to estimate the MID. Two established distribution-based approaches, the standardized effect size (ES) and standardized response mean (SRM) will be calculated. The anchor-based approach will be applied by using the global transition scale as the anchor.
6 weeks after completion of Non surgical Periodontal therapy

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 (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Navi Bansal Periodontics

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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