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

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotics
Sponsored by
Sunstar Americas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gingivitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Forsyth Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Probiotics Lozenge (twice a day)

Probiotics Lozenge (once a day)

Placebo Lozenge (once a day)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 11, 2013
Last Updated
November 3, 2017
Sponsor
Sunstar Americas
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1. Study Identification

Unique Protocol Identification Number
NCT01811316
Brief Title
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Official Title
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics Lozenge (twice a day)
Arm Type
Active Comparator
Arm Description
Subjects take their lozenge twice a day, one lozenge in the morning after brushing and one lozenge in the evening after brushing.
Arm Title
Probiotics Lozenge (once a day)
Arm Type
Active Comparator
Arm Description
Subjects take their lozenge once a day, one lozenge at night after brushing.
Arm Title
Placebo Lozenge (once a day)
Arm Type
Placebo Comparator
Arm Description
Subjects take their lozenge once a day, one lozenge at night after brushing.
Intervention Type
Other
Intervention Name(s)
Probiotics
Primary Outcome Measure Information:
Title
Change From Baseline in Modified Gingival Index (MGI)
Description
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.
Time Frame
4, 12 and 24 weeks
Title
Change From Baseline in Bleeding on Probing (BOP)
Description
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.
Time Frame
4, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Plaque Index (PI)
Description
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
Time Frame
4, 12 and 24 weeks
Title
Change From Baseline in Probing Depth (PD)
Description
Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.
Time Frame
4, 12 and 24 weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Inflammatory Markers in Gingival Crevicular
Description
Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.
Time Frame
15 days, 4, 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Hasturk, DDS, PhD
Organizational Affiliation
The Forsyth Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Forsyth Institute
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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