- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07615127
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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gaytri, BDS
- Numéro de téléphone: +91 9991092061
- E-mail: gaytrilalit901@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Dr. Rajinder Kumar Sharma, MDS
- Numéro de téléphone: +91 9416358222
- E-mail: rksharmamds@yahoo.in
Lieux d'étude
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Haryana
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Rohtak, Haryana, Inde
- Post Graduate Institute of dental sciences
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Contact:
- Dr. Rajender Kumar Sharma, MDS
- Numéro de téléphone: +91 9416358222
- E-mail: rksharmamds@yahoo.in
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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).
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Dental health utility state and oral health beliefs will be assessed through clinical examination and questionnaires.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dental Health State Utility value
Délai: 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
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Baseline
|
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Oral Health beliefs
Délai: baseline
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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
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baseline
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Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Dr. Rajinder Kumar Sharma, MDS, Post Graduate Institute Of Dental Sciences, Rohtak
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Gaytri Perio
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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