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

NCT01811316 | Completed Results

• 1 other identifier: CLP-2013-1-23
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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) 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.

  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 Outcomes (2)

• Change From Baseline in Plaque Index (PI)

  4, 12 and 24 weeks

• Change From Baseline in Probing Depth (PD)

  4, 12 and 24 weeks

Other Outcomes (1)

• Change From Baseline in Inflammatory Markers in Gingival Crevicular

  15 days, 4, 12 and 24 weeks

Study Arms (3)

Probiotics Lozenge (twice a day)

ACTIVE COMPARATOR

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

Other: Probiotics

Probiotics Lozenge (once a day)

ACTIVE COMPARATOR

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

Other: Probiotics

Placebo Lozenge (once a day)

PLACEBO COMPARATOR

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

Other: Probiotics

Interventions

Probiotics OTHER

Placebo Lozenge (once a day); Probiotics Lozenge (once a day); Probiotics Lozenge (twice a day)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (1)

The Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Akane Takemura
• Organization: Sunstar Americas, Inc.

akane.takemura@us.sunstar.com

+1-847-794-4276

Study Officials

• Hatice Hasturk, DDS, PhD

  The Forsyth Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 14, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 7, 2017
• Results First Posted: October 9, 2017

Record last verified: 2017-11

Locations

US (1)