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

Birmingham Community Healthcare NHS

Status: Completed

Conditions: Periodontitis

Treatments: Dietary Supplement: Placebo non active capsules; Dietary Supplement: Juice plus+

Study type: Interventional

Funder types: Other

Identifiers

NCT01229631

MULTI-NSA-10-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups, including a placebo group

Supplementation with non-active

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo non active capsules

Dietary supplementation with Juice plus+

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Juice plus+