NCT07304596

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 2, 2025

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Minimal Important Difference (MID)

    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

Study Arms (1)

Non Surgical Periodontal Therapy

OTHER

Full mouth Sub gingival instrumentation will be done

Procedure: Non Surgical Periodontal Therapy

Interventions

Full mouth subgingival instrumentation will be done

Non Surgical Periodontal Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 26, 2025

Study Start

November 12, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations