Periodontitis
Conditions
Keywords
Periodontitis, Dietary supplementation
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.
Interventions
DIETARY_SUPPLEMENTJuice plus+
Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months)
DIETARY_SUPPLEMENTPlacebo non active capsules
Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
Sponsors
University of Wuerzburg
Academic Centre for Dentistry in Amsterdam
Birmingham Community Healthcare NHS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical parameters | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and biochemical changes | 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 |
Countries
Germany, Netherlands, United Kingdom
Outcome results
None listed