A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sunstar Americas
ClinicalTrials.gov Identifier:
NCT01811316
First received: March 11, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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®.


Condition Intervention
Gingivitis
Other: Probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis

Resource links provided by NLM:


Further study details as provided by Sunstar Americas:

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: 60
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotics Lozenge (twice a day) Other: Probiotics
Active Comparator: Probiotics Lozenge (once a day) Other: Probiotics
Placebo Comparator: Placebo Lozenge (once a day) Other: Probiotics

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811316

Locations
United States, Massachusetts
The Forsyth Institute
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Sunstar Americas
Investigators
Principal Investigator: Hatice Hasturk, DDS, PhD The Forsyth Institute
  More Information

No publications provided

Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT01811316     History of Changes
Other Study ID Numbers: CLP-2013-1-23
Study First Received: March 11, 2013
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014