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Dietary Intakes and Periodontal Outcomes After Sanative Therapy

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ClinicalTrials.gov Identifier: NCT02291835
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Wendy E. Ward, Ph.D., Brock University

Tracking Information
First Submitted Date October 16, 2014
First Posted Date November 17, 2014
Last Update Posted Date August 28, 2018
Study Start Date January 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2014)
Periodontal healing evaluated based on changes in mean probing depth [ Time Frame: Baseline and between 8 and 16 weeks after sanative therapy ]
Healing is evaluated based on changes in mean probing depth
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 14, 2014)
  • Dietary nutrient intakes [ Time Frame: Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy) ]
    Dietary intakes were measured using the BLOCK food frequency questionnaire
  • Supplemental nutrient intakes [ Time Frame: Completed by participant anytime between study enrolment and follow-up (8 to 16 weeks after sanative therapy) ]
    Supplemental intakes were measured using a dietary supplement use questionnaire
  • Serum 25-hydroxyvitamin D concentrations [ Time Frame: Sample collected at baseline visit when sanative therapy was performed ]
    A venous blood sample was collected and sent to a medical laboratory for vitamin D testing.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Dietary Intakes and Periodontal Outcomes After Sanative Therapy
Official Title Dietary Intakes and Periodontal Outcomes After Sanative Therapy
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.
Detailed Description

Oral health, specifically the retention of teeth, is inextricably and positively linked with nutritional status of an individual. The emerging inter-relationships among obesity, type II diabetes metabolic syndrome, acute coronary syndrome and/or breast cancer with the etiology of periodontal disease identify nutrition as having a unique role in potentially modulating these complex relationships. Some nutrients such as vitamin D and fatty acids have been studied more extensively than other nutrients. Cross-sectional studies using National Health and Nutrition Examination Survey (NHANES) data or other cohorts have identified that individuals with higher intakes of vitamin D or omega-3 polyunsaturated fatty acids have a decreased risk of periodontal disease and tooth loss. One study has identified that individuals with better vitamin D status (measured as serum 25-hydroxyvitamin D) have better recovery after sanative therapy. Sanative therapy is a routine, first line cost-effective treatment to manage periodontal disease and thus prevent tooth loss. It is a non-surgical process involving mechanical debridement of bacterial biofilms on the roots of teeth, below the level of the gum line. Although one study has reported associations between vitamin D and outcomes after sanative therapy, the status of other nutrients or overall dietary patterns has not been assessed in relation to recovery from sanative therapy. The objective of this study was to determine if higher intakes of foods and nutrients with antioxidant or anti-inflammatory activity, including fruits, vegetables, β-carotene, vitamin C, vitamin D, vitamin E and omega-3 fatty acids were associated with reduced probing depth following sanative therapy.

The study took place at a periodontal clinic in Southern Ontario, Canada. Prior to enrolment, patients attended a consultation where a baseline periodontal examination, including measurement of probing depth at six sites per tooth was completed. Patients with chronic generalized periodontitis who were then prescribed sanative therapy as part of their treatment plan were invited to participate in the study. The study was explained to them and they were presented with a letter of invitation. Written consent was then obtained from patients wishing to participate.

Patients returned to the clinical approximately two months later for their sanative therapy appointment. Prior to meeting with the hygienist who performed sanative therapy, participants met with a study nurse. The nurse collected a venous blood sample, which was used for measurement of serum 25-hydroxyvitamin D concentrations. The nurse also measured participant's height, weight, waist circumference and hip circumference. After sanative therapy was performed, participants were provided with the Block Food Frequency Questionnaire and a supplement use questionnaire to be completed at home. Participants then returned to the clinic 8 -16 weeks later for their routine follow-up examination, which included measurement of periodontal probing depth. Additionally, information including participants age, sex, health conditions, medications, allergies and smoking habits was recorded from the medical forms that were completed during their consultation visit.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Probability Sample
Study Population Patients undergoing sanative therapy for the treatment of chronic generalized periodontitis.
Condition Periodontal Pocket
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Dodington DW, Fritz PC, Sullivan PJ, Ward WE. Higher Intakes of Fruits and Vegetables, β-Carotene, Vitamin C, α-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2014)
129
Original Actual Enrollment Same as current
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All adult patients undergoing sanative therapy were eligible.

Exclusion Criteria:

  • under 19 years of age
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02291835
Other Study ID Numbers BrockU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wendy E. Ward, Ph.D., Brock University
Study Sponsor Brock University
Collaborators Not Provided
Investigators
Principal Investigator: Wendy E Ward, PhD Professor
PRS Account Brock University
Verification Date August 2018