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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00952536 |
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Date of registration:
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03/08/2009 |
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Primary sponsor: |
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Public title:
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Effect of Dietary Intake of Dried Whole Food Concentrates (Juice Plus) on Clinical Outcomes Following Periodontal Therapy: A Pilot Study
BHAM-NSA-05-01 |
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Scientific title:
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The Effect of Daily Dietary Intake of Dried Whole Food Concentrates of Fruit, Vegetables and Berries (Juice Plus+) in Improving Clinical Outcomes Following Non-surgical Periodontal Therapy: a Pilot Study. |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00952536 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Iain LC Chapple, BDS FDS PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic periodontitis
- Presence of 2 or more sites per quadrant with pocketing or interproximal attachment
loss of greater than 6mm and 1/3rd radiographic bone loss
Exclusion Criteria:
- Subjects with aggressive disease
- Subjects with physical or mental disability
- Pregnant women
- Subjects whose medical history may place them at risk of complications from
periodontal therapy (e.g. need for antibiotic cover, warfarinised subjects)
- Subjects taking long term anti-microbial or anti-inflammatory drugs
- Subjects unable to swallow Juice Plus+ capsules
- Subjects unable to provide informed consent
- Current smokers
- Subjects taking regular vitamin supplementation
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontitis
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Intervention(s)
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Dietary Supplement: Daily Juice Plus+ vegetable & fruit & placebo capsule
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Dietary Supplement: Daily Juice Plus+ with vegetable & fruit & berry capsule
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Dietary Supplement: Placebo in the form of 6 capsules
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Primary Outcome(s)
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Primary outcome measure of healing will be increases in attachment level and reduction in probing pocket depths at 3-months.
[Time Frame: 3, 6 and 9-months]
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Secondary Outcome(s)
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Secondary outcome measures will be reduction in % sites with disclosed plaque (PS - measured dichotomously at 4 sites per tooth), reductions in gingival crevicular fluid (GCF) volume, increases in GCF and plasma TAOC.
[Time Frame: 3, 6 and 9-months]
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Secondary ID(s)
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BHAM-NSA-05-001 vs 11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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