Clinical trial NCT01229631: The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis
Official title: The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries (Juice Plus+) Upon Periodontal Outcomes in Chronic Periodontitis: A Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Dietary supplementation
Lead sponsor: Birmingham Community Healthcare NHS
Sponsor class: OTHER_GOV
Collaborators: name: University of Wuerzburg
name: Academic Centre for Dentistry in Amsterdam
First posted: 2010-10-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to standard non-surgical treatment.

Detailed description: The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to non-surgical treatment. In addition, the effects of supplementation prior to and following standard non-surgical management will be assessed, relative to a placebo supplemented group.

The investigators hypothesize that 3-months of nutritional support using this FVB will result in additional reductions in marginal gingival inflammation (bleeding) and additional reductions in probing pocket depth (mean \& cumulative), over and above any placebo-related or behavioral effect. In addition, the investigators hypothesize that 3-months of nutritional support prior to a standard non-surgical therapy in conjunction with a continuation of the nutritional support for 3 months will result in further additional reductions in marginal gingival inflammation and probing pocket depth, over and above any placebo-related or behavioral effect following standard non-surgical therapy.

Eligibility criteria: Inclusion Criteria:

* be aged 18 years old and over
* have a minimum of 20 teeth
* have chronic periodontitis
* be capable of giving informed consent themselves

Exclusion Criteria:

* Patients with aggressive disease
* Patients with physical or mental disability
* Pregnant women or those breastfeeding
* Patients whose medical history may place them at risk of complications from periodontal therapy (e.g. warfarinised Volunteers)
* Patients taking long term anti-microbial or anti-inflammatory drugs
* Patients unable to swallow the study capsules, or take 6 of these capsules a day
* Patients unable to provide informed consent
* Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils) or have taken them within 1-month of the study
* Shows unwillingness, inability or lack of motivation to carry out the study procedures or is not prepared to give written consent or to refrain from using other oral hygiene products (mouthwashes, chewing gum, water piks etc.) or to undergo professional dental cleaning for the duration of the study (other than as part of this protocol)
* Antibiotic or anti-inflammatory therapy currently or in previous two weeks
* Current orthodontic treatment
* Currently participating in another Dental Trial
* Diabetics

Primary outcomes:
measure: Changes in clinical parameters
timeFrame: 3 months
measure: Changes in clinical parameters
timeFrame: 6 months
Secondary outcomes:
measure: Clinical and biochemical changes
timeFrame: 3 months
measure: Clinical and biochemical changes
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
city: Amsterdam
country: Netherlands
facility: Academic Centre for Dentistry
city: Birmingham
country: United Kingdom
facility: Birmingham Dental Hospital & School
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Iain L Chapple, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wuerzburg
name: Ulrich Schlagenhauf, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Centre for Dentistry in Amsterdam
name: Ubele Van der Velden, PhD
role: PRINCIPAL_INVESTIGATOR
References: