Periodontitis Clinical Trial
— BHAM-NSA-05-01Official title:
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.
Verified date | February 2017 |
Source | Birmingham Community Healthcare NHS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There are 3 hypotheses to be tested:
1. That daily supplementation with Juice Plus+ will significantly improve treatment
outcomes over placebo supplementation, at 3-months post-therapy, when used as an
adjunct to conventional non-surgical periodontal therapy.
2. Triple therapy with Juice Plus+ (fruit, vegetable & berry) will produce additional
treatment benefit over dual therapy (fruit & vegetable) and over placebo.
3. Improved treatment outcomes with Juice Plus+ will be maintained at 9-months
post-therapy.
Brief Summary:
Periodontal diseases are highly prevalent chronic inflammatory diseases and a major cause of
tooth loss. Data supports an association between periodontitis prevalence and reduced serum
levels of antioxidants. Anecdotal reports from periodontal specialists indicate significant
improvements in clinical outcomes from periodontal therapy where adjunctive Juice Plus+ is
used, in agreement with research data from other systemic diseases where hyper-inflammation
is implicated in disease pathogenesis. There is however, a lack of scientific evidence from
clinical trials of periodontitis. Given the demonstrable antioxidant deficiency in
periodontitis patients (both locally and peripherally), the excess oxidative stress in
periodontitis patients, and the anecdotal evidence of clinical benefit from the adjunctive
use of Juice Plus+, this study proposes to investigate the impact of daily supplementation
with Juice Plus+ as an adjunct to traditional non-surgical periodontal therapy, in improving
therapeutic outcomes.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham Dental Hospital & Scool | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
Birmingham Community Healthcare NHS | NSA, LLC |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome measure of healing will be increases in attachment level and reduction in probing pocket depths at 3-months. | 3, 6 and 9-months | ||
Secondary | 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. | 3, 6 and 9-months |
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