NCT03073161|Completed
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Sponsor study identifier
observational
45
1 country
1
Study Start
January 1, 2017
Actual (reported)Primary Completion
June 30, 2018
Actual (reported)Study Completion
August 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2017
Actual (reported)March 3, 2017
Actual (reported)March 8, 2017
Actual (reported)June 30, 2018
Actual (reported)August 31, 2018
Actual (reported)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)
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)
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)
Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.
Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
Fonthill, Ontario, L0S1E5, Canada
Saliva is being collected for before and after sanative therapy for analysis of inflammatory markers.
Wendy E Ward, Ph.D.
Brock University
45 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2017
First Posted
March 8, 2017
Study Start
January 1, 2017
Actual (reported)Periodontal Changes Following Mid Maxillary Distraction
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2018
Actual (reported)Study Completion
August 31, 2018
Actual (reported)Last Updated
January 15, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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