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

NCT01229631 | Completed

• 1 other identifier: MULTI-NSA-10-001
• Study Type: interventional
• Target: 108
• Locations: 3 countries
• Sites: 3

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.

Conditions

Periodontitis

Keywords

Periodontitis; Dietary supplementation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Clinical and biochemical changes

  3 months

• Clinical and biochemical changes

  6 months

Study Arms (2)

Supplementation with non-active

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo non active capsules

Dietary supplementation with Juice plus+

ACTIVE COMPARATOR

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

Dietary Supplement: Juice plus+

Interventions

Juice plus+ 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)

Dietary supplementation with Juice plus+

Placebo non active capsules DIETARY_SUPPLEMENT

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

Supplementation with non-active

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be aged 18 years old and over
• have a minimum of 20 teeth
• have chronic periodontitis
• be capable of giving informed consent themselves

You may not qualify if:

• 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

Sponsors & Collaborators

• Birmingham Community Healthcare NHS: lead
• University of Wuerzburg: collaborator
• Academic Centre for Dentistry in Amsterdam: collaborator

Study Sites (3)

University of Wuerzburg

Würzburg, D-97070, Germany

Location

Academic Centre for Dentistry

Amsterdam, 1066 EA, Netherlands

Location

Birmingham Dental Hospital & School

Birmingham, West Midlands, B4 6NN, United Kingdom

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Iain L Chapple, BDS, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

• Ulrich Schlagenhauf, PhD

  University of Wuerzburg

  PRINCIPAL INVESTIGATOR

• Ubele Van der Velden, PhD

  Academic Centre for Dentistry in Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (PI to study)

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

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Study Start: May 22, 2017
• Primary Completion: June 30, 2017
• Study Completion: September 27, 2017
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

DE (1); GB (1); NL (1)