PeriodontitisENURGISENCT01229631
The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis
A study testing Juice plus+ in people with Periodontitis, run by Birmingham Community Healthcare NHS at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Juice plus+
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 May 2017to 27 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be aged 18 years old and over
- have a minimum of 20 teeth
- have chronic periodontitis
- be capable of giving informed consent themselves
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Birmingham Dental Hospital & School
Birmingham, West Midlands, B4 6NN
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Juice plus+, Placebo non active capsules
- Keywords
- Periodontitis, Dietary supplementation
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 capsulesDietary supplement
Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
| Study group | Role | What they receive |
|---|---|---|
| Supplementation with non-active | Placebo comparator | Subjects will be supplemented with placebo capsules (3 capsules am \& 3 capsules pm) Receives: Dietary Supplement: Placebo non active capsules |
| Dietary supplementation with Juice plus+ | Active comparator | Subjects will be supplemented with Juice plus+ capsules (3 capsules am \& 3 capsules pm) Receives: Dietary Supplement: Juice plus+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study start22 May 2017
- Primary completion30 Jun 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Community Healthcare NHS
- Sponsor type
- Other government
- Collaborators
- University of Wuerzburg, Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Professor I Chapple, Birmingham Community Healthcare NHS
- Investigators
- Iain L Chapple, BDS, PhD, Principal investigator, University of BirminghamUlrich Schlagenhauf, PhD, Principal investigator, University of WuerzburgUbele Van der Velden, PhD, Principal investigator, Academic Centre for Dentistry in Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229631
- Sponsor's protocol ID
- MULTI-NSA-10-001
- Acronym
- ENURGISE
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2010
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01229631
- Acronym / sponsor ID
- ENURGISE / MULTI-NSA-10-001
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Dietary supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Birmingham Community Healthcare NHSOther government
- Collaborators
- University of Wuerzburg, Academic Centre for Dentistry in Amsterdam
- Study start
- 22 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- longitudinal, randomised, block stratified (for smoking), double-blind, 2-arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Supplementation with non-active | Placebo comparator | Dietary Supplement: Placebo non active capsulesSubjects will be supplemented with placebo capsules (3 capsules am \& 3 capsules pm) |
| Dietary supplementation with Juice plus+ | Active comparator | Dietary Supplement: Juice plus+Subjects will be supplemented with Juice plus+ capsules (3 capsules am \& 3 capsules pm) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be aged 18 years old and over
- have a minimum of 20 teeth
- have chronic periodontitis
- be capable of giving informed consent themselves
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Dietary supplement | Dietary supplementation with Juice plus+ |
| Placebo non active capsulesSubjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months) | Dietary supplement | Supplementation with non-active |
Primary outcome
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).
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).
2 secondary outcomes
Clinical and biochemical changes
Time frame: 3 months
Clinical and biochemical changes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain L Chapple, BDS, PhD principal investigator
University of Birmingham
Ulrich Schlagenhauf, PhD principal investigator
University of Wuerzburg
Ubele Van der Velden, PhD principal investigator
Academic Centre for Dentistry in Amsterdam
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juice plus+ in people with Periodontitis, run by Birmingham Community Healthcare NHS at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clinical parameters (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.