A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
This study is currently recruiting participants.
Verified February 2014 by Sunstar Americas
Information provided by (Responsible Party):
First received: March 11, 2013
Last updated: February 11, 2014
Last verified: February 2014
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®.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
||A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Primary Outcome Measures:
- Change from Baseline in Modified Gingival Index (MGI) [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Bleeding on probing (BOP) [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in Plaque Index [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Probing Depth [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Change from Baseline in Inflammatory Markers in Gingival Crevicular [ Time Frame: 15 days, 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Active Comparator: Probiotics Lozenge (twice a day)
Active Comparator: Probiotics Lozenge (once a day)
Placebo Comparator: Placebo Lozenge (once a day)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
- 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.
- 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 ASA (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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811316
|The Forsyth Institute
|Cambridge, Massachusetts, United States, 02142 |
|Contact: Hatice Hasturk, DDS, PhD 617-892-8499 |
|Principal Investigator: Hatice Hasturk, DDS, PhD |
||Hatice Hasturk, DDS, PhD
||The Forsyth Institute
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 11, 2013
||February 11, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014