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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01811316
First Posted: March 14, 2013
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunstar Americas
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis

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 ]

    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 probin. 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.


Secondary Outcome Measures:
  • Change From Baseline in Plaque Index (PI) [ Time Frame: 4, 12 and 24 weeks ]

    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

    1. Separate flecks of plaque at the cervical margin of the tooth
    2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
    3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
    4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth
    5. Plaque covering two-thirds or more of the crown of the tooth

  • Change From Baseline in Probing Depth (PD) [ Time Frame: 4, 12 and 24 weeks ]
    Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.


Other Outcome Measures:
  • Change From Baseline in Inflammatory Markers in Gingival Crevicular [ Time Frame: 15 days, 4, 12 and 24 weeks ]
    Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.


Enrollment: 62
Study Start Date: March 2013
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: Probiotics
Active Comparator: Probiotics Lozenge (once a day)
Subjects take their lozenge once a day, one lozenge at night after brushing.
Other: Probiotics
Placebo Comparator: Placebo Lozenge (once a day)
Subjects take their lozenge once a day, one lozenge at night after brushing.
Other: Probiotics

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT01811316     History of Changes
Other Study ID Numbers: CLP-2013-1-23
First Submitted: March 11, 2013
First Posted: March 14, 2013
Results First Submitted: May 17, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: May 2017

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