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Dental Health State Utilities and Oral Health Beliefs in Periodontitis

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

112

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Haryana
      • Rohtak, Haryana, Indië
        • Post Graduate Institute of dental sciences
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Dental health utility state and oral health beliefs will be assessed through clinical examination and questionnaires.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dental Health State Utility value
Tijdsspanne: Baseline
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
Tijdsspanne: baseline
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Dr. Rajinder Kumar Sharma, MDS, Post Graduate Institute Of Dental Sciences, Rohtak

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

21 juni 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

30 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Parodontitis

Klinische onderzoeken op Health Utility State Assessment

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