Dietary Intakes and Periodontal Health: A Follow-Up Study

Dietary Intakes and Periodontal Outcomes After Sanative Therapy: A Follow-Up Study

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.

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 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 Type: Observational
• Enrollment (Actual): 43

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

Adult patients who previously underwent sanative therapy to manage periodontal disease and who have regular maintenance periodontal cleanings on a regular basis at the clinic.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)	Clinical Attachment Loss is a routine clinical measure of periodontal health (measured in mm)	At maintenance appointment (1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth	Probing depth is a routine clinical measure of periodontal health (measured in mm)	At maintenance appointment (1 hour)
Bleeding on Probing	Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth.	At maintenance appointment (1 hour)
Plaque Index	O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of the tooth.	At maintenance appointment (1 hour)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Markers of Inflammation	Specific markers of inflammation measured in saliva	At maintenance appointment (1 hour)
Dietary Nutrient Intakes	Dietary intakes measured using the Block food frequency questionnaire	At maintenance appointment (1 hour)
Tea Intakes	Quantity and type of tea consumed will be determined using a questionnaire	At maintenance appointment (1 hour)
Servings of Fruits, Vegetables and Fiber	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	At maintenance appointment (1 hour)
Dietary Supplement Intakes	Intakes of specific dietary supplements measured using a dietary supplement questionnaire	At maintenance appointment (1 hour)

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): April 1, 2018
• Study Completion (Actual): May 1, 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): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: flavonoids; 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: 16-131

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