A Study to Investigate Efficacy of Two Experimental Oral... | NCT02651467

NCT02651467

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)	Experimental	Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 1 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks.	Other: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)
Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)	Experimental	Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 2 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks.	Other: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )	Placebo Comparator	Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)	Other	1.5% w/w KOX, 0ppm F, pH 7.0	Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)	Schiff sensitivity score was assessed by 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.	Baseline and Week 8

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)	Schiff sensitivity score was assessed by 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.

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.
Participants will be 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 wellbeing 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.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Fort Wayne	Indiana	46825	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% weight by weight [w/w] KOX, 0 parts per million [ppm], pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info 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

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Other: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )

Safety population was defined as all the participants who were randomized and received at least one dose of study treatment during the study.

Arm/Group Information

ID	Title	Description
BG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
BG001	Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
BG002	Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00074 BG00174 BG00273 BG003221

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Schiff score at baseline

- ParticipantsOG00073
- ParticipantsOG00174
- ParticipantsOG00269

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.	ANCOVA		<0.0001	From ANCOVA model with treatment as factor and baseline Schiff score as covariate.	Difference of Least Square mean	-0.88			2-Sided	95	-1.181	-0.584			Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.		Superiority or Other

Secondary

Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)

Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Data shown for Treatment 1& 2 only for this endpoint. Baseline data only includes those participants who have a corresponding post-baseline assessment.

Posted

Mean

Standard Deviation

Score on a scale

Baseline and Week 8

ID	Title	Description
OG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.

Secondary

Change From Baseline in Schiff Sensitivity Score at Week 4

Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using 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 syimulus; 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.

Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Posted

Mean

Standard Deviation

Score on scale

Baseline and Week 4

ID	Title	Description
OG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
OG001	Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)

Secondary

Change From Baseline in Tactile Threshold at Week 4 and 8

Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth.

Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment.

Posted

Mean

Standard Deviation

grams

Baseline, Week 4 and 8

ID	Title	Description
OG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.

Secondary

Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8

Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").

Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Week 4 and 8

ID	Title	Description
OG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
OG001	Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.	74	74	4	74
EG001	Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.	74	74	2	74
EG002	Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )	Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.	73	73	5	73

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	Systematic Assessment	EG0001 affected74 at risk EG0010 events0 affected74 at risk EG0020 events0 affected73 at risk
MOUTH ULCERATION	Gastrointestinal disorders	Systematic Assessment	EG0001 affected74 at risk EG0010 events0 affected74 at risk EG0022 affected73 at risk
OEDEMA MOUTH	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 affected74 at risk EG0020 events0 affected73 at risk
SENSITIVITY OF TEETH	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected74 at risk EG0021 affected73 at risk
LIP ULCERATION	Gastrointestinal disorders	Systematic Assessment	EG0001 affected74 at risk EG0010 events0 affected74 at risk EG0020 affected73 at risk
BURN ORAL CAVITY	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected74 at risk EG0011 affected74 at risk EG0020 affected73 at risk
TRAUMATIC ULCER	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected74 at risk EG0021 affected73 at risk
BRONCHITIS	Infections and infestations	Systematic Assessment	EG0000 events0 affected74 at risk EG0010 events0 affected74 at risk EG0021 affected73 at risk

Title	Organization	Phone	Extension	Email
GSK Response Center	GlaxoSmithKline	866-435-7343

ID	Term
D003807	Dentin Sensitivity

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases