Clinical trial NCT03073161: Flavonoid Intake and Periodontal Healing
Official title: Flavonoid Intake and Periodontal Outcomes After Sanative Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Attachment Loss
Periodontal Pocket
Keywords: flavonoids
tea
dietary intake
nutritional supplements
periodontal disease
healing
sanative therapy
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
First posted: 2017-03-08
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.

Brief summary: Periodontitis is a chronic inflammatory disease that, if untreated, will lead to tooth loss. To treat periodontal disease, sanative therapy is used as a first line cost-effective strategy to manage periodontal disease and thus prevent tooth loss. Diet is emerging as a modifiable factor that may help an individual to more fully respond to treatments such as sanative therapy. Dietary flavonoids, abundant in fruits and tea, may be particularly beneficial. Patients with moderate to severe chronic generalized periodontitis and undergoing sanative therapy will be recruited for the study. Mean clinical attachment loss as well as other clinical measures will be assessed at baseline and 8 to 12 weeks following sanative therapy to measure periodontal healing. At baseline and follow-up appointment, the following will be assessed to examine associations with clinical measures of periodontal healing: intakes of macronutrients and micronutrients, fruits, vegetables and tea as well as supplement use and salivary markers of inflammation.

Detailed description: Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Sanative therapy is a non-surgical process invovling mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. A previous study found that a diet higher in fruits and vegetables, beta-carotene, vitamin C, alpha-tocopherol, and fish oils (specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) was positively associated with periodontal healing after sanative therapy. There is some evidence that higher intakes of flavonoids and thus flavonoid-containing foods may benefit periodontal health. These foods include a wide variety of fruits and tea. The relationship of flavonoid intake within the overall dietary pattern has not been assessed in relation to recovery from sanative therapy and associated markers of improved periodontal health. The overall objective is to determine if higher dietary flavonoid intakes are associated with improved clinical outcomes after sanative therapy compared to individuals with lower intakes. At baseline and the follow-up appointment, the following will be assessed: dietary intakes of macronutrients and micronutrients using the Block 2015 food frequency questionnaire; intakes of fruit, vegetables and fiber using the Block Dietary Fruit-Vegetable-Fiber Screener; nutritional supplement use and tea intake using in specially developed questionnaires and salivary markers of inflammation.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing sanative therapy for moderate to severe chronic generalized periodontitis. Chronic periodontitis is classified as generalized if \>30% of sites are involved. Severity of periodontitis is based on the amount of clinical attachment loss (CAL) with moderate and severe chronic generalized periodontitis defined as 3 to 4 mm CAL or \> 5 mm CAL, respectively.

Exclusion Criteria:

* under 19 years of age

Primary outcomes:
measure: Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
timeFrame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Secondary outcomes:
measure: Probing Depth
timeFrame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
measure: Bleeding on Probing
timeFrame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
measure: Plaque Index
timeFrame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Other outcomes:
measure: Dietary Nutrient Intakes
timeFrame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
measure: Tea Intakes
timeFrame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
measure: Servings of fruits, vegetables and fibre
timeFrame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
measure: Dietary Supplement Intakes
timeFrame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
measure: Salivary Markers of Inflammation
timeFrame: Measured at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
Locations:
city: Fonthill
country: Canada
facility: Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
state: Ontario
Study officials:
affiliation: Brock University
name: Wendy E Ward, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: