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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02370966
Date of registration: 12/02/2015
Prospective Registration: No
Primary sponsor: Kristianstad University
Public title: Berry Intake - Effects on Systemic and Oral Inflammation
Scientific title: Berry Intake - Effects on Systemic and Oral Inflammation
Date of first enrolment: February 2015
Target sample size: 18
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02370966
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 1/Phase 2
Countries of recruitment
Sweden
Contacts
Name:     Rutger Persson, PhD, DDS
Address: 
Telephone:
Email:
Affiliation:  University of Kristianstad
Key inclusion & exclusion criteria

Inclusion Criteria:

- minimum of 20 teeth

- bleeding on probing >25 %

- participate in routine dental examinations

Exclusion Criteria:

- on anti-inflammatory medication

- current treatment with antibiotics or intake of antibiotics 3 months before
participating in the study

- pregnancy

- smoker

- unwilling to refrain from nutraceuticals during the study period

- unwilling to give detailed information on diet intake during the study period



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Inflammation
Intervention(s)
Dietary Supplement: Berry powder
Primary Outcome(s)
Changes in the extent of gingivitis, as determined by severity of gingival bleeding, before and after study procedures. [Time Frame: Once a week over five weeks.]
Secondary Outcome(s)
Change in levels of vascular endothelial growth factor in serum, saliva and gingival fluid in relation to amount of berry intake before and after study procedures. [Time Frame: Once a week over five weeks.]
Change in levels of vascular endothelial growth factor in serum, saliva and gingival fluid in relation to gingival inflammation, as determined by severity of gingival bleeding, before and after study procedures. [Time Frame: Once a week over five weeks.]
Secondary ID(s)
KristianstadU
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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