NCT03073174

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

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, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

March 3, 2017

Last Update Submit

May 9, 2018

Conditions

Keywords

dietary intakenutritional supplementssanative therapyhealingflavonoidstea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Probing Depth

    At maintenance appointment (1 hour)

  • Bleeding on Probing

    At maintenance appointment (1 hour)

  • Plaque Index

    At maintenance appointment (1 hour)

Other Outcomes (5)

  • Dietary Nutrient Intakes

    At maintenance appointment (1 hour)

  • Tea Intakes

    At maintenance appointment (1 hour)

  • Servings of Fruits, Vegetables and Fiber

    At maintenance appointment (1 hour)

  • +2 more other outcomes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • previously participated in the original study (NCT02291835)

You may not qualify if:

  • under 19 years of age
  • have not participated in the previous study as this study is a direct follow-up of those participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 at time of hygiene appointment.

MeSH Terms

Conditions

Periodontal Attachment LossPeriodontal Pocket

Condition Hierarchy (Ancestors)

Periodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontitis

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

April 1, 2018

Study Completion

May 1, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations