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

NCT ID: NCT01811316

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

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®.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Probiotics Lozenge (twice a day)

Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: OTHER

Probiotics Lozenge (once a day)

Subjects take their lozenge once a day, one lozenge at night after brushing.

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: OTHER

Placebo Lozenge (once a day)

Subjects take their lozenge once a day, one lozenge at night after brushing.

Group Type: PLACEBO_COMPARATOR

Probiotics

Intervention Type: OTHER

Interventions

Probiotics

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunstar Americas

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hatice Hasturk, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

The Forsyth Institute

Locations

The Forsyth Institute

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

CLP-2013-1-23

Identifier Type: -

Identifier Source: org_study_id