The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis (ENURGISE)
Recruitment status was Recruiting
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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 |
- 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).
- 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: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (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 |
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| 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 | |
| University of Wuerzburg | Recruiting |
| Wuerzburg, Germany, D-97070 | |
| Principal Investigator: Ulrich Schlagenhauf, PhD | |
| Netherlands | |
| Academic Centre for Dentistry | Recruiting |
| Amsterdam, Netherlands, 1066 EA | |
| Principal Investigator: Ubele Van der Velden, PhD | |
| United Kingdom | |
| Birmingham Dental Hospital & School | Recruiting |
| Birmingham, West Midlands, United Kingdom, B4 6NN | |
| Principal Investigator: Iain L Chapple, BDS, PhD | |
| 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 Iain Chapple, University of Birmingham |
| ClinicalTrials.gov Identifier: | NCT01229631 History of Changes |
| Other Study ID Numbers: | MULTI-NSA-10-001 |
| Study First Received: | October 26, 2010 |
| Last Updated: | February 18, 2011 |
| 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:
|
Periodontitis Chronic Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013