Flavonoid Intake and Periodontal Healing

Flavonoid Intake and Periodontal Outcomes After Sanative Therapy

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Pocket; Periodontal Attachment Loss

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Fonthill, Ontario, Canada, L0S1E5
      • Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)	Periodontal healing is evaluated based on changes in clinical attachment loss (mm)	At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth	Periodontal healing is evaluated based on changes in probing depth (mm)	At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Bleeding on Probing	Inflammation is determined by percent of bleeding sites that are measured at 6 sites per tooth	At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Plaque Index	O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of a tooth	At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Nutrient Intakes	Dietary intakes measured using the BLOCK food frequency questionnaire	Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
Tea Intakes	Quantity of tea and type of tea consumed will be determined using a questionnaire	Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
Servings of fruits, vegetables and fibre	A questionnaire called the Block Fruit-Vegetable-Fiber Screener is used to provide a score that pertains to number of servings of fruits, vegetables and fiber consumed over past month	Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
Dietary Supplement Intakes	Intakes of specific dietary supplements measured using a dietary supplement questionnaire	Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)
Salivary Markers of Inflammation	Specific markers of inflammation measured in saliva	Measured at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)

Collaborators and Investigators

• Sponsor: Brock University
• Collaborators: Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
• Investigators: Principal Investigator: Wendy E Ward, Ph.D., Brock University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: flavonoids; periodontal disease; healing; tea; dietary intake; nutritional supplements; sanative therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Periodontitis; Periodontal Pocket; Periodontal Attachment Loss
• Other Study ID Numbers: 16-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No