Potential of Stannous Fluoride Toothpaste to Reduce Gum D... | NCT02750943

NCT02750943

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stannous Fluoride	Experimental	Participants will apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening)	Drug: Stannous Fluoride
Sodium Monofluorophosphate	Active Comparator	Participants will apply a full ribbon of dentifrice containing Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening)	Drug: Sodium Monofluorophosphate

Name	Type	Description	Arm Group Labels	Other Names
Stannous Fluoride	Drug	Dentifrice containing 0.454% w/w stannous fluoride	Stannous Fluoride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Bleeding Sites at Week 12	Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Number of Bleeding Sites at Week 4	Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
A minimum of 20 permanent gradable teeth. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
Moderate gingivitis present at the screening visit in the opinion of the investigator from a gross visual gingival assessment.
Visible blood in toothpaste expectorant at Screening and Baseline (Visit 2).

Exclusion Criteria:

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Women who are breast-feeding
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
Previous participation in this study.
Recent history (within the last year) of alcohol or other substance abuse.
An employee of the sponsor or the study site or members of their immediate family.
An employee of any toothpaste manufacturer or their immediate family.
Medical History/Current Medication A. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity B.Screening i. Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures.

ii. Currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.

iii. Currently taking a systemic medication which, in the opinion of the C. Baseline, Day 28 and Day 96 Assessment Visits i. Has taken antibiotics in the previous 14 days. ii. Has taken an anti-inflammatory medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days.

iii. Has taken a systemic medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).

Have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the subjects if they participate in the study.
Restorations in a poor state of repair.
Partial dentures or orthodontic appliances.
Teeth bleaching within 12 weeks of screening.
Use of a chlorhexidine mouthwash within 14 days of baseline.
Current smokers or smokers who have quit within the past 6 months prior to screening or subjects currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala or nicotine based e-cigarettes.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Las Vegas	Nevada	89146	United States

ID	Title	Description
FG000	Stannous Fluoride	Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
FG001	Sodium Monofluorophosphate	Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.

ID	Title	Description
BG000	Stannous Fluoride	Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
BG001	Sodium Monofluorophosphate

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

Number of Bleeding Sites at Week 12

Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.

Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 12 for respective treatment arm.

Posted

Least Squares Mean

Standard Error

number of bleeding sites

Week 12

ID	Title

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	Stannous Fluoride	Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.

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

ID	Term
D014002	Tin Fluorides
C012980	fluorophosphate

ID	Term
D005459	Fluorides
D006858	Hydrofluoric Acid
D017611	Fluorine Compounds
D007287	Inorganic Chemicals

OG000	Stannous Fluoride	Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
OG001	Sodium Monofluorophosphate	Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.