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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by NHS South Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Wuerzburg
Academic Centre for Dentistry in Amsterdam
Information provided by:
NHS South Birmingham
ClinicalTrials.gov Identifier:
NCT01229631
First received: October 26, 2010
Last updated: February 18, 2011
Last verified: October 2010

October 26, 2010
February 18, 2011
December 2010
July 2012   (final data collection date for primary outcome measure)
  • 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).

  • 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 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).

Complete list of historical versions of study NCT01229631 on ClinicalTrials.gov Archive Site
  • 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

  • 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, 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

Not Provided
Not Provided
 
The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Periodontitis
  • 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+
  • 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)
  • Placebo Comparator: Supplementation with non-active
    Subjects will be supplemented with placebo capsules (3 capsules am & 3 capsules pm)
    Intervention: Dietary Supplement: Placebo non active capsules
  • Active Comparator: Dietary supplementation with Juice plus+
    Subjects will be supplemented with Juice plus+ capsules (3 capsules am & 3 capsules pm)
    Intervention: Dietary Supplement: Juice plus+
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Iain L Chapple, BDS, PhD +441212372808 I.L.C.Chapple@bham.ac.uk
Contact: Mike R Milward, BDS, PhD +441212372808 M.R.milward@bham.ac.uk
Germany,   Netherlands,   United Kingdom
 
NCT01229631
MULTI-NSA-10-001
No
Professor Iain Chapple, University of Birmingham
NHS South Birmingham
  • University of Wuerzburg
  • Academic Centre for Dentistry in Amsterdam
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
NHS South Birmingham
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP