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

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Juice plus+
Placebo non active capsules
Sponsored by
Birmingham Community Healthcare NHS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Dietary supplementation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wuerzburg
  • Academic Centre for Dentistry
  • Birmingham Dental Hospital & School

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Supplementation with non-active

Dietary supplementation with Juice plus+

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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
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

Full Information

First Posted
October 26, 2010
Last Updated
March 14, 2019
Sponsor
Birmingham Community Healthcare NHS
Collaborators
University of Wuerzburg, Academic Centre for Dentistry in Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT01229631
Brief Title
The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Birmingham Community Healthcare NHS
Collaborators
University of Wuerzburg, Academic Centre for Dentistry in Amsterdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Dietary supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplementation with non-active
Arm Type
Placebo Comparator
Arm Description
Subjects will be supplemented with placebo capsules (3 capsules am & 3 capsules pm)
Arm Title
Dietary supplementation with Juice plus+
Arm Type
Active Comparator
Arm Description
Subjects will be supplemented with Juice plus+ capsules (3 capsules am & 3 capsules pm)
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice plus+
Intervention Description
Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo non active capsules
Intervention Description
Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
Primary Outcome Measure Information:
Title
Changes in clinical parameters
Description
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).
Time Frame
3 months
Title
Changes in clinical parameters
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical and biochemical changes
Description
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
Time Frame
3 months
Title
Clinical and biochemical changes
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iain L Chapple, BDS, PhD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich Schlagenhauf, PhD
Organizational Affiliation
University of Wuerzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ubele Van der Velden, PhD
Organizational Affiliation
Academic Centre for Dentistry in Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97070
Country
Germany
Facility Name
Academic Centre for Dentistry
City
Amsterdam
ZIP/Postal Code
1066 EA
Country
Netherlands
Facility Name
Birmingham Dental Hospital & School
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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