- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02291835
Dietary Intakes and Periodontal Outcomes After Sanative Therapy
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Oral health, specifically the retention of teeth, is inextricably and positively linked with nutritional status of an individual. The emerging inter-relationships among obesity, type II diabetes metabolic syndrome, acute coronary syndrome and/or breast cancer with the etiology of periodontal disease identify nutrition as having a unique role in potentially modulating these complex relationships. Some nutrients such as vitamin D and fatty acids have been studied more extensively than other nutrients. Cross-sectional studies using National Health and Nutrition Examination Survey (NHANES) data or other cohorts have identified that individuals with higher intakes of vitamin D or omega-3 polyunsaturated fatty acids have a decreased risk of periodontal disease and tooth loss. One study has identified that individuals with better vitamin D status (measured as serum 25-hydroxyvitamin D) have better recovery after sanative therapy. Sanative therapy is a routine, first line cost-effective treatment to manage periodontal disease and thus prevent tooth loss. It is a non-surgical process involving mechanical debridement of bacterial biofilms on the roots of teeth, below the level of the gum line. Although one study has reported associations between vitamin D and outcomes after sanative therapy, the status of other nutrients or overall dietary patterns has not been assessed in relation to recovery from sanative therapy. The objective of this study was to determine if higher intakes of foods and nutrients with antioxidant or anti-inflammatory activity, including fruits, vegetables, β-carotene, vitamin C, vitamin D, vitamin E and omega-3 fatty acids were associated with reduced probing depth following sanative therapy.
The study took place at a periodontal clinic in Southern Ontario, Canada. Prior to enrolment, patients attended a consultation where a baseline periodontal examination, including measurement of probing depth at six sites per tooth was completed. Patients with chronic generalized periodontitis who were then prescribed sanative therapy as part of their treatment plan were invited to participate in the study. The study was explained to them and they were presented with a letter of invitation. Written consent was then obtained from patients wishing to participate.
Patients returned to the clinical approximately two months later for their sanative therapy appointment. Prior to meeting with the hygienist who performed sanative therapy, participants met with a study nurse. The nurse collected a venous blood sample, which was used for measurement of serum 25-hydroxyvitamin D concentrations. The nurse also measured participant's height, weight, waist circumference and hip circumference. After sanative therapy was performed, participants were provided with the Block Food Frequency Questionnaire and a supplement use questionnaire to be completed at home. Participants then returned to the clinic 8 -16 weeks later for their routine follow-up examination, which included measurement of periodontal probing depth. Additionally, information including participants age, sex, health conditions, medications, allergies and smoking habits was recorded from the medical forms that were completed during their consultation visit.
Type d'étude
Inscription (Réel)
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:
- All adult patients undergoing sanative therapy were eligible.
Exclusion Criteria:
- under 19 years of age
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Periodontal healing evaluated based on changes in mean probing depth
Délai: Baseline and between 8 and 16 weeks after sanative therapy
|
Healing is evaluated based on changes in mean probing depth
|
Baseline and between 8 and 16 weeks after sanative therapy
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dietary nutrient intakes
Délai: Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy)
|
Dietary intakes were measured using the BLOCK food frequency questionnaire
|
Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy)
|
|
Supplemental nutrient intakes
Délai: Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy)
|
Supplemental intakes were measured using a dietary supplement use questionnaire
|
Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy)
|
|
Serum 25-hydroxyvitamin D concentrations
Délai: Sample collected at baseline visit when sanative therapy was performed
|
A venous blood sample was collected and sent to a medical laboratory for vitamin D testing.
|
Sample collected at baseline visit when sanative therapy was performed
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wendy E Ward, PhD, Professor
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 (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
- BrockU
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