- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gaytri, BDS
- Phone Number: +91 9991092061
- Email: gaytrilalit901@gmail.com
Study Contact Backup
- Name: Dr. Rajinder Kumar Sharma, MDS
- Phone Number: +91 9416358222
- Email: rksharmamds@yahoo.in
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India
- Post Graduate Institute of dental sciences
-
Contact:
- Dr. Rajender Kumar Sharma, MDS
- Phone Number: +91 9416358222
- Email: rksharmamds@yahoo.in
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental Health State Utility value
Time Frame: Baseline
|
Health state utility values elicited using the Standard Gamble method using questionnaires.
|
Baseline
|
|
Oral Health beliefs
Time Frame: baseline
|
Oral Health beliefs using Health belief model questionnaire
|
baseline
|
Collaborators and Investigators
Investigators
- Study Director: Dr. Rajinder Kumar Sharma, MDS, Post graduate institute of dental sciences, Rohtak
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gaytri Perio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
-
Mahsa UniversityRecruitingPeriodontitis | Periodontitis Chronic Generalized Moderate | Periodontitis (Stage 3) | Periodontitis, Adult | Periodontitis Chronic Generalized Severe | Periodontitis, Chronic | Periodontitis Stage II | Periodontitis Chronic Localized Slight | Periodontitis Stage IIIMalaysia
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingPeriodontitis Stage II | Periodontitis Stage III | Periodontitis Stage IV
-
Misr University for Science and TechnologyCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Cairo UniversityRecruitingPeriodontitis | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Ataturk UniversityCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage IITurkey (Türkiye)
-
Al-Azhar UniversityNot yet recruitingStage IV Periodontitis | Advanced Periodontitis | Stage III PeriodontitisEgypt
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
University Hospital HeidelbergRecruitingPeriodontitis (Stage 3) | Periodontitis, Adult | Periodontitis Stage IVGermany
-
Akdeniz UniversityNot yet recruitingPeriodontitis (Stage 3) | Periodontitis Stage IVTurkey (Türkiye)
-
Gülnur EmingilEge University Scientific Research Projects Coordination UnitCompletedPeriodontitis (Stage 3) | Periodontitis Stage IIITurkey (Türkiye)
Clinical Trials on Health Utility State Assessment
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingFatigue | Motivation | Cerebral InjuryFrance
-
The Opole University of TechnologyCompleted
-
Assistance Publique Hopitaux De MarseilleRecruitingInherited Metabolic Diseases Requiring Restrictive and Specific DietFrance
-
German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnUnknownSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockGermany
-
Philip KernNot yet recruiting
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingBrain Tumor | Metastatic Brain TumorUnited States
-
Çankırı Karatekin UniversityHacettepe UniversityCompleted
-
University of CalgaryAlberta Children's Hospital Research InstituteEnrolling by invitation
-
National Cancer Centre, SingaporeRecruiting
-
Haseki Training and Research HospitalActive, not recruitingPostoperative Cognitive Dysfunction | Neurocognitive Disorder | Laparoscopic Abdominal Surgery | Dexmedetomidine Infusion | Postoperative Cognitive Dysfunction(POCD)Turkey