Periodontal Disease Prevention Study
Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease
This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis.
The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes.
Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.
Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.
To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk."
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Michigan
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Ann Arbor, Michigan, États-Unis, 48106
- Michigan Center for Oral Health Research
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.
Exclusion Criteria:
- Organ transplant recipients are excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
|---|
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Low Risk Experimental Group
1 visit - Low Risk ~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
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Low risk Control Group
2 visits - Low Risk ~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
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High Risk Experimental Group
1 visit - High Risk ~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
|
High Risk Control Group
2 visits - High Risk ~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With Tooth Loss Over 16 Year Period
Délai: 16 years
|
Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.
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16 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change in Total Dental Claims During Monitoring Period
Délai: 10 and 15 years
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10 and 15 years
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Change in Total Periodontal Claims During the Monitoring Period
Délai: 10 and 15 years
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10 and 15 years
|
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Change in Periodontal Surgery Claims
Délai: 10 and 15 years
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10 and 15 years
|
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Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.
Délai: 10 and 15 years
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10 and 15 years
|
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Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories
Délai: 10 and 15 years
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10 and 15 years
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM00037624
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
produit fabriqué et exporté des États-Unis.
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