Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Wuerzburg
Academic Centre for Dentistry in Amsterdam
Information provided by (Responsible Party):
Professor I Chapple, NHS South Birmingham
ClinicalTrials.gov Identifier:
NCT01229631
First received: October 26, 2010
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Periodontitis
Dietary Supplement: Juice plus+
Dietary Supplement: Placebo non active capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by NHS South Birmingham:

Primary Outcome Measures:
  • Changes in clinical parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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).

  • Changes in clinical parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • Clinical and biochemical changes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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

  • Clinical and biochemical changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 90
Study Start Date: December 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Supplementation with non-active
Subjects will be supplemented with placebo capsules (3 capsules am & 3 capsules pm)
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)
Active Comparator: Dietary supplementation with Juice plus+
Subjects will be supplemented with Juice plus+ capsules (3 capsules am & 3 capsules pm)
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)
Other Name: Juice plus+

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229631

Locations
Germany
University of Wuerzburg
Wuerzburg, Germany, D-97070
Netherlands
Academic Centre for Dentistry
Amsterdam, Netherlands, 1066 EA
United Kingdom
Birmingham Dental Hospital & School
Birmingham, West Midlands, United Kingdom, B4 6NN
Sponsors and Collaborators
NHS South Birmingham
University of Wuerzburg
Academic Centre for Dentistry in Amsterdam
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Professor I Chapple, Professor (PI to study), NHS South Birmingham
ClinicalTrials.gov Identifier: NCT01229631     History of Changes
Other Study ID Numbers: MULTI-NSA-10-001
Study First Received: October 26, 2010
Last Updated: September 24, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS South Birmingham:
Periodontitis
Dietary supplementation

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 27, 2014