NCT02291835

Brief Summary

Periodontitis is a chronic inflammatory disease and a significant risk factor for tooth loss. While a link between diet and periodontal health exists, the relationship between diet and healing following periodontal therapy has yet to be investigated.The objective of this study was to determine if higher intakes of foods and nutrients with antioxidant or anti-inflammatory activity are associated with reduced probing depth following sanative therapy. Sanative therapy is a first line cost-effective treatment to manage periodontal disease and thus prevent tooth loss. Patients with chronic generalized periodontitis undergoing sanative therapy were recruited for the study. Mean probing depth was assessed at baseline and 8-16 weeks following sanative therapy. Dietary intakes of fruits, vegetables, vitamins and dietary fats were estimated using the Block 2005 food frequency questionnaire and supplement use was recorded using a questionnaire. A small venous blood sample was also collected at baseline to measure serum 25-hydroxyvitamin D concentrations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

October 16, 2014

Last Update Submit

August 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Periodontal healing evaluated based on changes in mean probing depth

    Healing is evaluated based on changes in mean probing depth

    Baseline and between 8 and 16 weeks after sanative therapy

Other Outcomes (3)

  • Dietary nutrient intakes

    Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy)

  • Supplemental nutrient intakes

    Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy)

  • Serum 25-hydroxyvitamin D concentrations

    Sample collected at baseline visit when sanative therapy was performed

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All adult patients undergoing sanative therapy were eligible.

You may not qualify if:

  • under 19 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dodington DW, Fritz PC, Sullivan PJ, Ward WE. Higher Intakes of Fruits and Vegetables, beta-Carotene, Vitamin C, alpha-Tocopherol, EPA, and DHA Are Positively Associated with Periodontal Healing after Nonsurgical Periodontal Therapy in Nonsmokers but Not in Smokers. J Nutr. 2015 Nov;145(11):2512-9. doi: 10.3945/jn.115.211524. Epub 2015 Sep 30.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Wendy E Ward, PhD

    Professor

    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 in Bone and Muscle Development

Study Record Dates

First Submitted

October 16, 2014

First Posted

November 17, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 28, 2018

Record last verified: 2018-08