NCT07615127

Brief Summary

This observational, cross-sectional study addresses gaps in periodontal health economics by measuring dental health state utility values (HSUVs) for periodontitis treatment. While Oral Health Related Quality of Life outcomes dominate current research, Health State Utility values are rarely measured and seldom applied . The few existing utility studies are methodologically limited. The primary aim is to measure Health state utility values for periodontal health states using direct elicitation methods ( Standard Gamble) in patients with clinically diagnosed periodontitis. The secondary aim is to examine associations between patient-elicited utility values, clinical periodontal status (CAL, PD, BoP), and psychosocial beliefs from the Health Belief Model including perceived susceptibility, severity, benefits, and barriers. Participants will complete utility tasks and Health belief model questionnaires in a single visit. By integrating preference-based utility measurement with clinical and psychosocial constructs, this study will provide essential data for cost-utility modelling of periodontal interventions and support patient-centered care.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

June 21, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 22, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

PeriodontitisDenatl health state utility valueoral health beliefshealth beliefs model

Outcome Measures

Primary Outcomes (2)

  • Dental Health State Utility value

    Health state utility values elicited using the Standard Gamble method using questionnaires having minimum value:0 and maximum value:1. Higher score indicates better perceived dental health state. A score of 1 represents perfect dental health and 0 represents a state equivalent to death

    Baseline

  • Oral Health beliefs

    Oral Health beliefs using Health belief model questionnaire for periodontal disease. It is a 15 items questionnaire using a 5-point Likert scale from1 = strongly disagree to 5= strongly agree. Minimum score: 15 to maximum score: 75. Higher score indicate stronger positive oral health beliefs regarding periodontal disease susceptibility and severity

    baseline

Study Arms (1)

Periodontitis Patients

Patients aged 30-50 years with a clinical diagnosis of periodontitis according to the 2017 World Workshop Classification. Complete periodontal examination will be done comprising of recording pocket probing depth (PPD), clinical attachment level (CAL) at six sites per tooth, bleeding on probing (BoP), plaque index (PI) and gingival index(GI).

Other: Health Utility State Assessment

Interventions

Dental health utility state and oral health beliefs will be assessed through clinical examination and questionnaires.

Periodontitis Patients

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 30- 50 years attending the outpatient Department of Periodontology with a confirmed clinical diagnosis of periodontitis based on the 2017 World Workshop Classification. Participants were recruited consecutively from routine clinical appointments. All participants had at least 20 natural teeth, no history of periodontal surgery in the past 6 months, and were able to complete utility elicitation tasks and self-administered questionnaires . Patients with history of antibiotic use within last 3 months, steroid, immunosuppressive and psychiatric drug use or pregnancy were excluded.

You may qualify if:

  • Adult patients with age group 30-50 years diagnosed with generalized periodontitis.
  • Presence of minimum 20 teeth excluding third molars
  • Able to read/understand Hindi or English (for questionnaires)

You may not qualify if:

  • Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
  • History of Periodontal treatment within last 6 months
  • History of Antibiotic use within the previous 3 months
  • History of Steroid, immunosuppressive and psychiatric drug use
  • Pregnant and lactating women
  • History of Smoking or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of dental sciences

Rohtak, Haryana, India

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Dr. Rajinder Kumar Sharma, MDS

    Post graduate institute of dental sciences, Rohtak

    STUDY DIRECTOR

Central Study Contacts

Dr. Rajinder Kumar Sharma, MDS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start (Estimated)

June 21, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

There are no plans to make individual participant data available. This is a postgraduate thesis study. De-identified data will be maintained by the principal investigator at the institution in accordance with institutional ethics committee requirements

Locations