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

Study Overview
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Brief Summary
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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®.

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

Conditions
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Gingivitis

Intervention / Treatment
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* Other: Probiotics


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics Lozenge (twice a day)<br>Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing. | Other: Probiotics<br> <br> |
| Active Comparator: Probiotics Lozenge (once a day)<br>Subjects take their lozenge once a day, one lozenge at night after brushing. | Other: Probiotics<br> <br> |
| Placebo Comparator: Placebo Lozenge (once a day)<br>Subjects take their lozenge once a day, one lozenge at night after brushing. | Other: Probiotics<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Modified Gingival Index (MGI) | 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) Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit Mild inflammation of the entire gingival unit Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit 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. | 4, 12 and 24 weeks | 
| Change From Baseline in Bleeding on Probing (BOP) | Bleeding on probing was assessed 30 seconds after probing. 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. | 4, 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plaque Index (PI) | 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 Separate flecks of plaque at the cervical margin of the tooth A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth A band of plaque wider than one mm but covering less than one-third of the crown of the tooth Plaque covering at least one-third but less than two-thirds of the crown of the tooth Plaque covering two-thirds or more of the crown of the tooth | 4, 12 and 24 weeks | 
| Change From Baseline in Probing Depth (PD) | Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm. | 4, 12 and 24 weeks |