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NCT Number: NCT01229631

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wuerzburg, Würzburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Changes in clinical parameters

    Time frame: 3 months

    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).

  2. Changes in clinical parameters

    Time frame: 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 outcomes

  1. Clinical and biochemical changes

    Time frame: 3 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, 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

  2. Clinical and biochemical changes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Birmingham Community Healthcare NHS

Other Gov

Collaborators

  • Academic Centre for Dentistry in Amsterdam
  • University of Wuerzburg

Registry information

Official study 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

Acronym: ENURGISE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2010
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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