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Flavonoid Intake and Periodontal Healing

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ClinicalTrials.gov Identifier: NCT03073161
Recruitment Status : Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
Information provided by (Responsible Party):
Wendy E. Ward, Ph.D., Brock University

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.

Condition or disease
Periodontal Attachment Loss Periodontal Pocket

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
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Flavonoid Intake and Periodontal Outcomes After Sanative Therapy
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 31, 2018



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


Secondary Outcome Measures :
  1. Probing Depth [ Time Frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy) ]
    Periodontal healing is evaluated based on changes in probing depth (mm)

  2. Bleeding on Probing [ Time Frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy) ]
    Inflammation is determined by percent of bleeding sites that are measured at 6 sites per tooth

  3. Plaque Index [ Time Frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy) ]
    O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of a tooth


Other Outcome Measures:
  1. Dietary Nutrient Intakes [ Time Frame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy) ]
    Dietary intakes measured using the BLOCK food frequency questionnaire

  2. Tea Intakes [ Time Frame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy) ]
    Quantity of tea and type of tea consumed will be determined using a questionnaire

  3. Servings of fruits, vegetables and fibre [ Time Frame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy) ]
    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

  4. Dietary Supplement Intakes [ Time Frame: Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy) ]
    Intakes of specific dietary supplements measured using a dietary supplement questionnaire

  5. Salivary Markers of Inflammation [ Time Frame: Measured at baseline and follow-up (8 to 12 weeks after completion of sanative therapy) ]
    Specific markers of inflammation measured in saliva


Biospecimen Retention:   Samples With DNA
Saliva is being collected for before and after sanative therapy for analysis of inflammatory markers.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073161


Locations
Canada, Ontario
Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
Fonthill, Ontario, Canada, L0S1E5
Sponsors and Collaborators
Brock University
Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
Investigators
Principal Investigator: Wendy E Ward, Ph.D. Brock University

Responsible Party: Wendy E. Ward, Ph.D., Professor and Canada Research Chair, Brock University
ClinicalTrials.gov Identifier: NCT03073161     History of Changes
Other Study ID Numbers: 16-114
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wendy E. Ward, Ph.D., Brock University:
flavonoids
tea
dietary intake
nutritional supplements
periodontal disease
healing
sanative therapy

Additional relevant MeSH terms:
Periodontal Pocket
Periodontal Attachment Loss
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy