GingivitisNCT01811316
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
A study testing Probiotics in people with Gingivitis, run by Sunstar Americas at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to read, understand and sign an Informed Consent form.
- Good general health as evidenced by the medical history.
- Between 18 and 65 years of age.
- Male or female.
- Minimum of 20 teeth, excluding crowns and third molar teeth.
- Mean whole mouth Modified Gingival Index of greater-than or equal to 2.0 at baseline.
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- Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits.
- Willing to abstain from eating and drinking in the morning of visits, only drinking water is allowed.
- Willing to abstain from interdental cleaning, chewing gums, oral whitening, mouth rinse and tobacco products for the study duration.
- Able to understand and follow study directions.
- No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Who cannot join
- Presence of orthodontic appliances.
- Intra-oral soft tissue lesions due to pathology or trauma
- Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of PI.
- More than two sites with pocket depth >5mm and concomitant attachment loss of >2mm.
- Pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
- Use of antibiotics within 3 months of enrollment
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- History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc)
- Chronic use of medication such as steroids, NSAIDs (more than 2-3 days/week), anti-coagulant medications, immunosuppressant medications or any other medications that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of acetylsalicylic acid (81 mg) is permitted.
- Unwilling to sign a confidentiality statement and/or return the test products.
- Medical condition which requires pre-medication prior to dental visits/procedures.
- Immune compromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Current use of probiotics or probiotic containing food (i.e., yogurt)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Forsyth Institute
Cambridge, Massachusetts, 02142
About this study
The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.
- Conditions
- Gingivitis
- Being tested
- Probiotics
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Lozenge (twice a day) | Active comparator | Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing. Receives: Other: Probiotics |
| Probiotics Lozenge (once a day) | Active comparator | Subjects take their lozenge once a day, one lozenge at night after brushing. Receives: Other: Probiotics |
| Placebo Lozenge (once a day) | Placebo comparator | Subjects take their lozenge once a day, one lozenge at night after brushing. Receives: Other: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Gingival Index (MGI)
Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation)
- Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit
- Mild inflammation of the entire gingival unit
- Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit
- Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.
Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites.
Measured: 4, 12 and 24 weeks
Change From Baseline in Bleeding on Probing (BOP)
Bleeding on probing was assessed 30 seconds after probing. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.
Measured: 4, 12 and 24 weeks
Secondary outcomes (2)
Change From Baseline in Plaque Index (PI)
Plaque Index of Turesky Modification of Quigley-Hein (Turesky, Gilmore et al. 1970) (PI) was scored on all natural teeth (except third molars) after disclosing with erythrosine solution. Scores Criteria:
0 No plaque
- Separate flecks of plaque at the cervical margin of the tooth
- A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
- A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
- Plaque covering at least one-third but less than two-thirds of the crown of the tooth
- Plaque covering two-thirds or more of the crown of the tooth
Measured: 4, 12 and 24 weeks
Change From Baseline in Probing Depth (PD)
Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.
Measured: 4, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GingivitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunstar Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hatice Hasturk, DDS, PhD, Principal investigator, The Forsyth Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811316
- Sponsor's protocol ID
- CLP-2013-1-23
- Status last verified
- Nov 2017
- First submitted
- 11 Mar 2013
- Last updated
- 7 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
- ClinicalTrials.gov ID
- NCT01811316
- Acronym / sponsor ID
- CLP-2013-1-23
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 9 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. The primary purpose of this study is to support claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics Lozenge (twice a day) | Active comparator | Other: ProbioticsSubjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing. |
| Probiotics Lozenge (once a day) | Active comparator | Other: ProbioticsSubjects take their lozenge once a day, one lozenge at night after brushing. |
| Placebo Lozenge (once a day) | Placebo comparator | Other: ProbioticsSubjects take their lozenge once a day, one lozenge at night after brushing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing and able to read, understand and sign an Informed Consent form.
- Good general health as evidenced by the medical history.
- Between 18 and 65 years of age.
- Male or female.
- Minimum of 20 teeth, excluding crowns and third molar teeth.
Key exclusion criteria (12 listed)
- Presence of orthodontic appliances.
- Intra-oral soft tissue lesions due to pathology or trauma
- Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of PI.
- More than two sites with pocket depth >5mm and concomitant attachment loss of >2mm.
- Pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
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 |
|---|---|---|
| Probiotics | Other | Placebo Lozenge (once a day), Probiotics Lozenge (once a day), Probiotics Lozenge (twice a day) |
Primary outcome
Change From Baseline in Modified Gingival Index (MGI)
Time frame: 4, 12 and 24 weeks
Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation) 1. Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit 2. Mild inflammation of the entire gingival unit 3. Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit 4. Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit. Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites.
Change From Baseline in Bleeding on Probing (BOP)
Time frame: 4, 12 and 24 weeks
Bleeding on probing was assessed 30 seconds after probing. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.
2 secondary outcomes
Change From Baseline in Plaque Index (PI)
Time frame: 4, 12 and 24 weeks
Change From Baseline in Probing Depth (PD)
Time frame: 4, 12 and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hatice Hasturk, DDS, PhD principal investigator
The Forsyth Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Gingivitis, run by Sunstar Americas at 1 site in United States.
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 11 inclusion and 12 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 7 Dec 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Modified Gingival Index (MGI) (time frame: 4, 12 and 24 weeks). 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 7 Dec 2017.