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Completed

NCT Number: NCT03073161

Flavonoid Intake and Periodontal Healing

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.

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Key information

Conditions

Periodontal Attachment Loss Mouth Diseases Periodontal Atrophy Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery

Fonthill, Ontario, L0S1E5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brock University

Other

Collaborators

  • Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery

Registry information

Official study title

Flavonoid Intake and Periodontal Outcomes After Sanative Therapy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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