Post Graduate Institute of dental sciences
Rohtak, Haryana, India
NCT Number: NCT07615127
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 opening soon.
Get Notified30 year–50 year
All sexes
Observational
Rohtak, Haryana, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dental health utility state and oral health beliefs will be assessed through clinical examination and questionnaires.
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Dr. Rajinder Kumar Sharma, MDS
CONTACT
Gaytri, BDS
CONTACT
Postgraduate Institute of Dental Sciences Rohtak
Other
Association of Dental Health State Utility Values and Oral Health Beliefs With Staging and Grading of Periodontitis: A Cross-sectional Evaluation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07482878
Mouth Diseases, Periodontal Diseases
Vienna, State of Vienna, Austria
View Trial DetailsNCT07688408
Mouth Diseases, Periodontal Disease
Guarulhos, São Paulo, Brazil
View Trial DetailsNCT07651579
Mouth Diseases, Periodontal Diseases
Clermont-Ferrand, France
View Trial DetailsNCT07665489
Chronic Disease, Chronic Periodontitis
Clermont-Ferrand, France
View Trial Details