Study Investigating Efficacy of an Occluding Dentifrice f... | NCT02705716

NCT02705716

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
Test Dentifrice	Experimental	Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants will then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute.	Other: 0.454% w/w stannous fluoride (1100ppm fluoride)
Control Dentifrice	Placebo Comparator	Participants will be instructed to apply a full brush head of toothpaste containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants will then brush the whole mouth thoroughly for at least 1 minute.	Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)

Name	Type	Description	Arm Group Labels	Other Names
0.454% w/w stannous fluoride (1100ppm fluoride)	Other	Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)	Test Dentifrice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Schiff Sensitivity Score on Day 14	Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.	Baseline, Day 14

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Schiff Sensitivity Score on Day 7	Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

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.
Participant is male or female aged between 18 and 65 years inclusive.
Good general and mental health with, in the opinion of the investigator or medically qualified designee.
No clinically significant and relevant abnormalities in medical history or upon oral examination.
Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements.
Self-reported history of dentinal hypersensitivity (DH) lasting more than(>) six months but not > 10 years.
Good general oral health, with a minimum of 20 natural teeth.
Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.

Exclusion Criteria:

Women who are pregnant or breast-feeding .
Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
Any condition which, in the opinion of the investigator, causes xerostomia.
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.
Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants.
Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
Teeth bleaching within eight weeks of Screening.
Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the Investigator.
Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening.
Individuals who require antibiotic prophylaxis for dental procedures.
Any participant who, in the judgment of the investigator, should not participate in the study.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ellesmere Port	Cheshire	CH65 4BW	United Kingdom
GSK Investigational Site

Arm/Group Information

ID	Title	Description
FG000	Test Dentifrice	Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
FG001	Control Dentifrice	Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Test Dentifrice	Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.

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 Schiff Sensitivity Score on Day 14

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 14.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Day 14

ID	Title	Description

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	Test Dentifrice	Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

OG000	Test Dentifrice	Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
OG001	Control Dentifrice	Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.