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

Periodontitis Clinical Trial

— ENURGISE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229631
• Other study ID #: MULTI-NSA-10-001
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: September 27, 2017

Study information

• Verified date: March 2019
• Source: Birmingham Community Healthcare NHS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 27, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Dietary Supplement:
• 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)
• Placebo non active capsules
Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)

Locations

Country	Name	City	State
Germany	University of Wuerzburg	Wuerzburg
Netherlands	Academic Centre for Dentistry	Amsterdam
United Kingdom	Birmingham Dental Hospital & School	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
Birmingham Community Healthcare NHS	Academic Centre for Dentistry in Amsterdam, University of Wuerzburg

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in clinical parameters	The primary outcomes will be differences in the changes in the below parameters at 3-months post-supplementation between test and placebo groups: % sites with marginal bleeding on probing (BOP) from baseline.; Probing pocket depth reductions (mm) from baseline (expressed as reductions in mean and also cumulative pocket depth).	3 months
Primary	Changes in clinical parameters	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).	6 months
Secondary	Clinical and biochemical changes	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, clinical attachment level (CAL) measures (mm), recession (mm), gingival redness (MGI).; Biochemical outcomes in plasma -carbonyls, 8OHdG (from buffy coats), isoprostanes, vitamin C, beta-carotene	3 months
Secondary	Clinical and biochemical changes	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	6 months