Flavonoid Intake and Periodontal Healing

NCT03073161 | Completed

• 1 other identifier: 16-114
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Attachment Loss; Periodontal Pocket

Keywords

flavonoids; tea; dietary intake; nutritional supplements; periodontal disease; healing; sanative therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Probing Depth

  At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)

• Bleeding on Probing

  At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)

• Plaque Index

  At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)

Other Outcomes (5)

• Dietary Nutrient Intakes

  Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)

• Tea Intakes

  Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)

• Servings of fruits, vegetables and fibre

  Completed at baseline and follow-up (8 to 12 weeks after completion of sanative therapy)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.

You may qualify if:

• 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.

You may not qualify if:

• under 19 years of age

Sponsors & Collaborators

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

Study Sites (1)

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

Fonthill, Ontario, L0S1E5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva is being collected for before and after sanative therapy for analysis of inflammatory markers.

MeSH Terms

Conditions

Periodontal Attachment Loss; Periodontal Pocket; Periodontal Diseases

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases; Periodontitis

Study Officials

• Wendy E Ward, Ph.D.

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Canada Research Chair

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 31, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)