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- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gaytri, BDS
- Número de teléfono: +91 9991092061
- Correo electrónico: gaytrilalit901@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Dr. Rajinder Kumar Sharma, MDS
- Número de teléfono: +91 9416358222
- Correo electrónico: rksharmamds@yahoo.in
Ubicaciones de estudio
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Haryana
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Rohtak, Haryana, India
- Post Graduate Institute of dental sciences
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Contacto:
- Dr. Rajender Kumar Sharma, MDS
- Número de teléfono: +91 9416358222
- Correo electrónico: rksharmamds@yahoo.in
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dental Health State Utility value
Periodo de tiempo: Baseline
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Health state utility values elicited using the Standard Gamble method using questionnaires.
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Baseline
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Oral Health beliefs
Periodo de tiempo: baseline
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Oral Health beliefs using Health belief model questionnaire
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baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Dr. Rajinder Kumar Sharma, MDS, Post graduate institute of dental sciences, Rohtak
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Gaytri Perio
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Periodontitis
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Mahsa UniversityReclutamientoPeriodontitis | Periodontitis Crónica Generalizada Moderada | Periodontitis (Etapa 3) | Periodontitis Del Adulto | Periodontitis Crónica Generalizada Severa | Periodontitis Crónica | Periodontitis Etapa II | Periodontitis Crónica Localizada Leve | Periodontitis estadio IIIMalasia
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Shanghai Ninth People's Hospital Affiliated to...Aún no reclutandoPeriodontitis Etapa II | Periodontitis estadio III | Periodontitis Estadio IV
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Misr University for Science and TechnologyTerminadoPeriodontitis | Periodontitis Etapa I | Periodontitis Etapa II | Periodontitis estadio IIIEgipto
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Cairo UniversityReclutamientoPeriodontitis | Periodontitis Etapa II | Periodontitis estadio IIIEgipto
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Ataturk UniversityTerminadoPeriodontitis | Periodontitis Etapa I | Periodontitis Etapa IITurquía (Türkiye)
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Akdeniz UniversityAún no reclutandoPeriodontitis (Etapa 3) | Periodontitis Estadio IVTurquía (Türkiye)
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Gülnur EmingilEge University Scientific Research Projects Coordination UnitTerminadoPeriodontitis (Etapa 3) | Periodontitis estadio IIITurquía (Türkiye)
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University Hospital HeidelbergReclutamientoPeriodontitis (Etapa 3) | Periodontitis Del Adulto | Periodontitis Estadio IVAlemania
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Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraTerminadoPeriodontitis Agresiva | Periodontitis Del AdultoItalia
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RANA AHMADAún no reclutandoPeriodontitis apical sintomática | Pulpitis irreversible con periodontitis apical