Skip to main content
OpenTrials
Completed

NCT Number: NCT03073174

Dietary Intakes and Periodontal Health: 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.

Completed

Looking for future studies?

Notify Me

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)

    Time frame: At maintenance appointment (1 hour)

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

Secondary outcomes

  1. Probing Depth

    Time frame: At maintenance appointment (1 hour)

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

  2. Bleeding on Probing

    Time frame: 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

    Time frame: 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 outcomes

  1. Dietary Nutrient Intakes

    Time frame: At maintenance appointment (1 hour)

    Dietary intakes measured using the Block food frequency questionnaire

  2. Tea Intakes

    Time frame: At maintenance appointment (1 hour)

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

  3. Servings of Fruits, Vegetables and Fiber

    Time frame: 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

    Time frame: At maintenance appointment (1 hour)

    Intakes of specific dietary supplements measured using a dietary supplement questionnaire

  5. Salivary Markers of Inflammation

    Time frame: At maintenance appointment (1 hour)

    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

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
May 11, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.