Clinical trial NCT01811316: A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Official title: A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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®.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria

* 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
* 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)

Primary outcomes:
measure: Change From Baseline in Modified Gingival Index (MGI)
timeFrame: 4, 12 and 24 weeks
measure: Change From Baseline in Bleeding on Probing (BOP)
timeFrame: 4, 12 and 24 weeks
Secondary outcomes:
measure: Change From Baseline in Plaque Index (PI)
timeFrame: 4, 12 and 24 weeks
measure: Change From Baseline in Probing Depth (PD)
timeFrame: 4, 12 and 24 weeks
Other outcomes:
measure: Change From Baseline in Inflammatory Markers in Gingival Crevicular
timeFrame: 15 days, 4, 12 and 24 weeks
Locations:
city: Cambridge
country: United States
facility: The Forsyth Institute
state: Massachusetts
Study officials:
affiliation: The Forsyth Institute
name: Hatice Hasturk, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: