Overview

This trial is active, not recruiting.

Condition periodontitis
Treatments juice plus+, placebo non active capsules
Phase phase 2
Sponsor NHS South Birmingham
Collaborator University of Wuerzburg
Start date December 2010
End date December 2014
Trial size 90 participants
Trial identifier NCT01229631, MULTI-NSA-10-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Subjects will be supplemented with placebo capsules (3 capsules am & 3 capsules pm)
placebo non active capsules
Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
(Active Comparator)
Subjects will be supplemented with Juice plus+ capsules (3 capsules am & 3 capsules pm)
juice plus+ Juice plus+
Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months)

Primary Outcomes

Measure
Changes in clinical parameters
time frame: 3 months
Changes in clinical parameters
time frame: 6 months

Secondary Outcomes

Measure
Clinical and biochemical changes
time frame: 3 months
Clinical and biochemical changes
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
Principal investigator Iain L Chapple, BDS, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by NHS South Birmingham.