The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2017-09-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplementation with non-active

Subjects will be supplemented with placebo capsules (3 capsules am \& 3 capsules pm)

Group Type PLACEBO_COMPARATOR

Placebo non active capsules

Intervention Type DIETARY_SUPPLEMENT

Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)

Dietary supplementation with Juice plus+

Subjects will be supplemented with Juice plus+ capsules (3 capsules am \& 3 capsules pm)

Group Type ACTIVE_COMPARATOR

Juice plus+

Intervention Type DIETARY_SUPPLEMENT

Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Placebo non active capsules

Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No