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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03073161
Other study ID # 16-114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date August 31, 2018

Study information

Verified date January 2019
Source Brock University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery Fonthill Ontario

Sponsors (2)

Lead Sponsor Collaborator
Brock University Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Primary 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 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)
Secondary 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)
Secondary 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)
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