Dietary Intakes and Periodontal Health: A Follow-Up Study

Sponsor
Brock University (Other)
Overall Status
Completed
CT.gov ID
NCT03073174
Collaborator
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery (Other)
43
1
15.9
2.7

Study Details

Study Description

Brief Summary

A previous study, on which this study is based, 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 (NCT02291835). The investigator's next step, in the present study, is to determine long-term benefits of sanative therapy in which patients have regular maintenance hygiene cleanings on periodontal health. Specifically, the relationship between intakes of specific foods, nutrients and supplements with clinical periodontal outcomes will be studied.

Condition or Disease Intervention/Treatment Phase

    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 involving mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. Participants in this present study previously underwent sanative therapy several years ago and have been attending the clinic for regular maintenance appointments to maintain periodontal health. While significant associations were observed with higher intakes of fruits and vegetables and specific nutrients (vitamins C and E, beta-carotene, fish oils) within a few months after sanative therapy, this study will follow-up these findings to determine if such relationships persist during a period of relatively stable periodontal health. Given new insights into a potential role of flavonoids in maintaining periodontal health, this aspect will also be studied. The overall objective is to determine if higher intakes of foods, nutrients and supplements known to have osteogenic and immunomodulatory effects are associated with improved clinical outcomes in individuals who previously underwent sanative therapy. At the regular maintenance appointment, clinical measures will be evaluated (clinical attachment loss, probing depth, bleeding on probing, plaque index). As well, the following will be evaluated: 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 specially developed questionnaires and salivary markers of inflammation using biochemical assays.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dietary Intakes and Periodontal Outcomes After Sanative Therapy: A Follow-Up Study
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Apr 1, 2018
    Actual Study Completion Date :
    May 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss) [At maintenance appointment (1 hour)]

      Clinical Attachment Loss is a routine clinical measure of periodontal health (measured in mm)

    Secondary Outcome Measures

    1. Probing Depth [At maintenance appointment (1 hour)]

      Probing depth is a routine clinical measure of periodontal health (measured in mm)

    2. Bleeding on Probing [At maintenance appointment (1 hour)]

      Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth.

    3. Plaque Index [At maintenance appointment (1 hour)]

      O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of the tooth.

    Other Outcome Measures

    1. Dietary Nutrient Intakes [At maintenance appointment (1 hour)]

      Dietary intakes measured using the Block food frequency questionnaire

    2. Tea Intakes [At maintenance appointment (1 hour)]

      Quantity and type of tea consumed will be determined using a questionnaire

    3. Servings of Fruits, Vegetables and Fiber [At maintenance appointment (1 hour)]

      A questionnaire called the Block Fruit-Vegtable-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 [At maintenance appointment (1 hour)]

      Intakes of specific dietary supplements measured using a dietary supplement questionnaire

    5. Salivary Markers of Inflammation [At maintenance appointment (1 hour)]

      Specific markers of inflammation measured in saliva

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • previously participated in the original study (NCT02291835)
    Exclusion Criteria:
    • under 19 years of age

    • have not participated in the previous study as this study is a direct follow-up of those participants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery Fonthill Ontario Canada L0S1E5

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Wendy E Ward, Ph.D., Brock University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wendy E. Ward, Ph.D., Professor and Canada Research Chair, Brock University
    ClinicalTrials.gov Identifier:
    NCT03073174
    Other Study ID Numbers:
    • 16-131
    First Posted:
    Mar 8, 2017
    Last Update Posted:
    May 11, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    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., Professor and Canada Research Chair, Brock University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2018