Evaluation of Responsiveness of Hindi Version of Oral Health Impact Profile for Periodontitis (OHIP-P-HIN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Minimal Important Difference (MID)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Non Surgical Periodontal Therapy
Full mouth Sub gingival instrumentation will be done
Intervention: Non Surgical Periodontal Therapy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported