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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Dietary Supplement: Placebo non active capsules; Dietary Supplement: Juice plus+

• Registration Number: NCT01229631
• Lead Sponsor: Birmingham Community Healthcare NHS

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.

Study Timeline

• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Study Start: 2017-05-22
• Primary Completion: 2017-06-30
• Study Completion: 2017-09-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplementation with non-active	Placebo non active capsules	Subjects will be supplemented with placebo capsules (3 capsules am \& 3 capsules pm)
Dietary supplementation with Juice plus+	Juice plus+	Subjects will be supplemented with Juice plus+ capsules (3 capsules am \& 3 capsules pm)

Primary Outcome Measures

Name	Time	Method
Changes in clinical parameters	6 months	The primary outcomes will be differences in the changes in the parameters listed below at 6 months (3 months post supplementation + 3 months post treatment)in test and placebo groups; % sites with marginal BOP from baseline. Probing pocket depth reductions (mm) from baseline (expressed as reductions in mean and also cumulative pocket depth).

Secondary Outcome Measures

Name	Time	Method
Clinical and biochemical changes	6 months	Secondary outcome measures will be clinical and biochemical and include differences in the changes in the below between test and placebo groups: Patient outcomes - oral health quality of life Clinical outcomes - % sites BOP from pocket base from baseline, CAL measures (mm), recession (mm), gingival redness (MGI).; Biochemical outcomes in plasma -carbonyls, 8OHdG (from buffy coats), isoprostanes, vitamin C, beta-carotene

Trial Locations

Locations (3)

Birmingham Dental Hospital & School; 🇬🇧 Birmingham, West Midlands, United Kingdom

University of Wuerzburg; 🇩🇪 Wuerzburg, Germany

Academic Centre for Dentistry; 🇳🇱 Amsterdam, Netherlands