GingivitisPhase 2NCT01954849
Assessment of a Probiotic to Treat Gingivitis in Pediatric Patients
A Phase 2 study testing Probiotic formulation in people with Gingivitis and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Gingivitis, Inflammation
- What is being tested?
- Probiotic formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Dec 2014
- Phase
- Phase 2
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are male or female between the ages of 11 to 18 years
- Have mild to moderate gingivitis as determined by dentist (GI of at least 1 to a maximum of 2)
- Are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars for a minimum of 5 months.
- Have fully erupted teeth #16, #21, #23, #36, #41, and #43
- Are caries inactive prior to study initiation.
- Are in a healthy systemic condition
- Have not used any antimicrobial mouth rinses, probiotics (unrelated to the study), antibiotics or anti-inflammatories medications with one month prior to and during the study
- Whose legal guardian has given informed consent to participate in the study and must be able to communicate in English
Who cannot join
- Unable to make informed consent
- Subjects with allergies to milk or milk products, gluten or soy or any other ingredients present in the lozenge
- Immune compromised
- Major underlining medical condition
- Pregnancy
- History of smoking or alcohol consumption
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- Have major dental conditions such as periodontal disease, dental caries and/or xerostemia or systemic diseases which could directly or indirectly affect plaque formation
- Use of medications within 1 month (antibiotics, anti-inflammatory, mouth rinses) that can influence the outcome.
- Ongoing or recent (within 1 month) use of probiotics unrelated to the study
- Have within the past 30 days experienced any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto Orthodontics Clinic
Toronto, Ontario, M5S 2J7
About this study
Official title: Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis
This study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this study will be randomly assigned to receive either the probiotic treatment or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. They will also be assessed for the same measures at day 56, following a 28-day wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/or inflammatory cytokines.
- Conditions
- Gingivitis, Inflammation
- Being tested
- Probiotic formulation
- Keywords
- gingivitis, inflammation, plaque, orthodontics
- Medical subject headings
- Gingivitis, Inflammation, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic formulationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic formulation | Experimental | Probiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days. Receives: Dietary Supplement: Probiotic formulation |
| Placebo | Placebo comparator | Placebo dissolving lozenge, with the exact same appearance as the treatment lozenge (including flavour, colour, shape and texture), and formulated with all the same ingredients except for the live bacteria, taken for 28 days at the same prescribed regimen as the probiotic lozenge. Receives: Dietary Supplement: Probiotic formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in gingivitis
Gingivitis will be assessed by gingival index:
0 - Absence of gingival inflammation
- - Mild inflammation: slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit
- - Mild inflammation: criteria as above, but involving the entire marginal or papillary gingival unit
- - Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit
- - Severe inflammation: marked redness, edema, and/or hypertrophy of marginal or papillary gingival unit; spontaneous bleeding, congestion or ulceration.
Measured: 0, 14, 28, and 56 days
Secondary outcomes (2)
Reduced plaque
Reduction in levels of plaque as measured by a plaque index:
0 - No plaque in the gingival area
- - A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. Only seen by running a probe across the tooth surface
- - Moderate accumulation of plaque deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye
- - Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface
Measured: 0, 14, 28, and 56 days
Reduction in inflammation
Reduction in salivary cytokines IL-1, IL-6, IL-8, TNF-A, IL-12 and an increase in IL-10, and IL-13 as measured by immunofluorometric assay.
Measured: 0, 14, 28, and 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Integra Medical Inc., University of Toronto, University of Western Ontario, Canada, Ontario Centres of Excellence
- Responsible party
- Principal investigator, Peter Cadieux, University of Western Ontario, Canada
- Investigators
- Peter Cadieux, PhD, Principal investigator, University of Western Ontario, CanadaSiew-Ging Gong, BDS, MS, MA, PhD., Study director, University of Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954849
- Sponsor's protocol ID
- LG-001
- Other IDs
- 185428, OCE VIP #20964
- Status last verified
- Aug 2015
- First submitted
- 26 Sep 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Therapeutic Potential of a Novel Dental Probiotic in Pediatric Patients Affected by Gingivitis
- ClinicalTrials.gov ID
- NCT01954849
- Acronym / sponsor ID
- LG-001
- Conditions
- Gingivitis, Inflammation
- Keywords
- gingivitis, inflammation, plaque, orthodontics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Integra Medical Inc., University of Toronto, University of Western Ontario, Canada, Ontario Centres of Excellence
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Oct 2013 (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.
This study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. Patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. Participants in this study will be randomly assigned to receive either the probiotic treatment or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. The lozenges are to be taken orally at a certain prescribed regimen for 28 days. Participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. They will also be assessed for the same measures at day 56, following a 28-day wash-out phase. Plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/or inflammatory cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic formulation | Experimental | Dietary Supplement: Probiotic formulationProbiotic dissolving lozenge, at least 1 billion total CFU, taken at a certain prescribed regimen for 28 days. |
| Placebo | Placebo comparator | Dietary Supplement: Probiotic formulationPlacebo dissolving lozenge, with the exact same appearance as the treatment lozenge (including flavour, colour, shape and texture), and formulated with all the same ingredients except for the live bacteria, taken for 28 days at the same prescribed regimen as the probiotic lozenge. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Are male or female between the ages of 11 to 18 years
- Have mild to moderate gingivitis as determined by dentist (GI of at least 1 to a maximum of 2)
- Are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars for a minimum of 5 months.
- Have fully erupted teeth #16, #21, #23, #36, #41, and #43
- Are caries inactive prior to study initiation.
Key exclusion criteria (10 listed)
- Unable to make informed consent
- Subjects with allergies to milk or milk products, gluten or soy or any other ingredients present in the lozenge
- Immune compromised
- Major underlining medical condition
- Pregnancy
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 |
|---|---|---|
| Probiotic formulation | Dietary supplement | Placebo, Probiotic formulation |
Primary outcome
Reduction in gingivitis
Time frame: 0, 14, 28, and 56 days
Gingivitis will be assessed by gingival index: 0 - Absence of gingival inflammation 1. - Mild inflammation: slight change in colour, little change in texture of any portion of but not the entire marginal or papillary gingival unit 2. - Mild inflammation: criteria as above, but involving the entire marginal or papillary gingival unit 3. - Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4. - Severe inflammation: marked redness, edema, and/or hypertrophy of marginal or papillary gingival unit; spontaneous bleeding, congestion or ulceration.
2 secondary outcomes
Reduced plaque
Time frame: 0, 14, 28, and 56 days
Reduction in inflammation
Time frame: 0, 14, 28, and 56 days
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 19 Aug 2015.
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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.
Peter Cadieux, PhD principal investigator
University of Western Ontario, Canada
Siew-Ging Gong, BDS, MS, MA, PhD. study director
University of Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic formulation in people with Gingivitis and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 inclusion and 10 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in gingivitis (time frame: 0, 14, 28, and 56 days). 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 19 Aug 2015.