A Clinical Trial to Evaluate Long-term Efficacy and Safet... | NCT01811316

NCT01811316

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Other		Placebo Lozenge (once a day) Probiotics Lozenge (once a day) Probiotics Lozenge (twice a day)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

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)

Name	Affiliation	Role
Hatice Hasturk, DDS, PhD	The Forsyth Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Forsyth Institute		Cambridge	Massachusetts	02142	United States

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Probiotics Lozenge (Once a Day)	Subjects take their lozenge once a day, one lozenge at night after brushing.
FG002	Placebo Lozenge (Once a Day)	Subjects take their lozenge once a day, one lozenge at night after brushing.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Probiotics Lozenge (Once a Day)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

One subject was lost to follow up between 4 and 12 weeks.

Posted

Mean

Standard Deviation

units on a scale

4, 12 and 24 weeks

ID	Title	Description
OG000	Probiotics Lozenge (Twice a Day)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena