- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02291835
Dietary Intakes and Periodontal Outcomes After Sanative Therapy
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- All adult patients undergoing sanative therapy were eligible.
Exclusion Criteria:
- under 19 years of age
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Periodontal healing evaluated based on changes in mean probing depth
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Dietary nutrient intakes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Wendy E Ward, PhD, professor
Pubblicazioni e link utili
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BrockU
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