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PeriodontitisNCT07615127

Dental Health State Utilities and Oral Health Beliefs in Periodontitis

An observational study of Periodontitis and Dental Health Utility Value, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 50 years
What is being tested?
Health Utility State Assessment
Type of treatment
Pill or oral medicine
How many people
112 participants
Where
1 siteIndia
Study dates
21 Jun 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Rajinder Kumar Sharma, MDS contact

+91 9416358222

rksharmamds@yahoo.in

India1 site
  • Post Graduate Institute of dental sciences

    Rohtak, Haryana

    Dr. Rajender Kumar Sharma, MDS, +91 9416358222, rksharmamds@yahoo.in

Other trials in India

About this study

Official title: Association of Dental Health State Utility Values and Oral Health Beliefs With Staging and Grading of Periodontitis: A Cross-sectional Evaluation

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.

Read the detailed description

Periodontal disease is a highly prevalent chronic inflammatory condition and remains a leading cause of tooth loss worldwide. In addition to functional impairment, untreated periodontitis has significant psychosocial consequences, negatively affecting eating, speech, appearance, and overall quality of life. Research consistently shows that periodontitis is associated with poorer oral health-related quality of life (OHRQoL), with improvements observed following periodontal therapy.

However, while OHRQoL tools such as the Oral Health Impact Profile (OHIP) are valuable for capturing patient-reported outcomes, they are not preference-based measures and therefore cannot be directly used for health economic evaluations. In health economics, health state utility values are essential because they allow outcomes to be expressed on a standardized scale from 0 (death) to 1 (perfect health), enabling calculation of quality-adjusted life years (QALYs). This permits direct comparison of dental interventions with other healthcare services in cost-utility analyses. Despite this importance, HSUVs remain underutilized in dentistry, with only limited attempts made to derive utility values for periodontal health states. Most periodontal cost-effectiveness studies continue to rely on intermediate clinical outcomes, such as probing depth reduction, rather than patient-centered utility measures, which limits their policy relevance. Health state utility values can be elicited using either direct methods such as the Standard Gamble (SG) and Time Trade-Off (TTO), or indirect instruments like the EQ-5D. Direct methods capture individual preferences by asking patients to make trade-offs between life expectancy, health states, or risk of death, whereas indirect instruments classify health across domains and apply population preference weights.

While indirect tools are widely used in medicine, they are often criticized for lacking sensitivity to oral health conditions, which may underestimate the true burden of periodontitis. Adapting direct elicitation methods to periodontal health contexts is therefore necessary to generate valid and meaningful utility values. Beyond clinical outcomes, patients' valuation of periodontal treatment may be shaped by psychological and behavioural constructs. The Health Belief Model (HBM) suggests that perceptions of susceptibility, severity, benefits, and barriers strongly influence oral health behaviours. Evidence from periodontology confirms that compliance with oral hygiene instructions and adoption of preventive behaviours are associated with patients' health beliefs. More recently, psychosocial traits such as self-efficacy and self-esteem have been identified as predictors of the degree of OHRQoL improvement following periodontal therapy. This highlights the possibility that oral health beliefs also play a role in how patients assign utility values to treatment outcomes Current evidence shows that OHRQoL outcomes still dominate periodontal research, while Health state utility values are rarely measured and seldom applied in economic evaluations. The few studies that have attempted to quantify utility values for periodontal treatment have been methodologically limited, and little is known about the role of oral health beliefs in shaping how patients assign value to treatment. Addressing these gaps is essential for generating robust evidence that reflects both economic efficiency and patient-centered perspectives. Therefore, this study aims to measure dental health state utility values for periodontal treatment and to examine their association with clinical periodontal status and oral health beliefs. By integrating dental health state utility values measurement with psychosocial constructs, the study will provide data essential for cost-utility modelling and patient-centered care.

Being tested
Health Utility State Assessment
Keywords
Periodontitis, Denatl health state utility value, oral health beliefs, health beliefs model
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Utility State AssessmentOther

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

Study groups in NCT07615127
Study groupRoleWhat they receive
Periodontitis PatientsPatients 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).
Receives: Other: Health Utility State Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start21 Jun 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07615127
Sponsor's protocol ID
Gaytri Perio
Status last verified
May 2026
First submitted
22 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Dental Health Utility Value, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaytri, BDS (+91 9991092061, gaytrilalit901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental Health State Utility value (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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