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| Name | Class |
|---|---|
| University of Wuerzburg | OTHER |
| Academic Centre for Dentistry in Amsterdam | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementation with non-active | Placebo Comparator | Subjects will be supplemented with placebo capsules (3 capsules am & 3 capsules pm) |
|
| Dietary supplementation with Juice plus+ | Active Comparator | Subjects will be supplemented with Juice plus+ capsules (3 capsules am & 3 capsules pm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 months |
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wuerzburg | Würzburg | D-97070 | Germany | |||
| Academic Centre for Dentistry |
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longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
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| 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) |
|
| 3 months |
| 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 | 6 months |
| Amsterdam |
| 1066 EA |
| Netherlands |
| Birmingham Dental Hospital & School | Birmingham | West Midlands | B4 6NN | United Kingdom |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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