Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

• ClinicalTrials.gov Identifier: NCT02773758
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Results First Posted: December 12, 2016
• Last Update Posted: September 29, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dentin Sensitivity
• Interventions: Other: Stannous Fluoride Dentifrice; Other: Sodium monofluorophosphate Dentifrice
• Enrollment: 143

Participant Flow

Recruitment Details	Participants were recruited at a single center in Canada.
Pre-assignment Details	A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized.

Arm/Group Title	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
Arm/Group Description	Participants were 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), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.	Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Period Title: Overall Study
Started	71	70
Completed	71	70
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice	Total
Arm/Group Description		Participants were 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), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.	Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.	Total of all reporting groups
Overall Number of Baseline Participants		72	69	141
Baseline Analysis Population Description		One participant was randomized to sodium monofluorophosphate dentifrice but received stannous fluoride dentifrice, therefore, treatment arm "stannous fluoride dentifrice" included 72 participants & treatment arm "sodium monofluorophosphate dentifrice" included 69 participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	72 participants	69 participants	141 participants
		47.7 (10.27)	48.0 (10.58)	47.9 (10.39)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	72 participants	69 participants	141 participants
	Female	55 76.4%	50 72.5%	105 74.5%
	Male	17 23.6%	19 27.5%	36 25.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Schiff Sensitivity Score at Day 14
Description	Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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.
Time Frame	Baseline, Day 14

Outcome Measure Data

Analysis Population Description

Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
Arm/Group Description:	Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.	Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Overall Number of Participants Analyzed	71	70
Mean (Standard Deviation); Unit of Measure: score on a scale
At Baseline	2.70 (0.427)	2.74 (0.423)
Change From Baseline at Day 14	-1.38 (0.843)	-0.10 (0.405)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride Dentifrice, Sodium Monofluorophosphate Dentifrice
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.
Method of Estimation	Estimation Parameter	Least square (LS) mean difference
	Estimated Value	-1.29
	Confidence Interval	(2-Sided) 95%; -1.509 to -1.071
	Estimation Comments	Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.

2. Secondary Outcome

Title	Change From Baseline in Schiff Sensitivity Score at Day 7
Description	Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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.
Time Frame	Baseline, Day 7

Outcome Measure Data

Analysis Population Description

Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
Arm/Group Description:	Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.	Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Overall Number of Participants Analyzed	71	70
Mean (Standard Deviation); Unit of Measure: score on a scale
At Baseline	2.70 (0.427)	2.74 (0.423)
Change from baseline at Week 7	-0.74 (0.446)	-0.04 (0.374)

3. Secondary Outcome

Title	Change From Baseline in Tactile Threshold at Day 7 and Day 14
Description	A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.
Time Frame	Baseline, Day 7 and Day 14

Outcome Measure Data

Analysis Population Description

Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
Arm/Group Description:	Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.	Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
Overall Number of Participants Analyzed	71	70
Mean (Standard Deviation); Unit of Measure: gram (g)
At Baseline	11.83 (3.189)	11.50 (2.992)
Change from Baseline at Day 7	5.92 (6.113)	0.86 (3.898)
Change from Baseline at Day 14	15.21 (11.663)	0.86 (3.708)

Adverse Events

Time Frame	From start of screening to 5 days following last administration of the study product (up to 39 days)
Adverse Event Reporting Description	Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" & 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
Arm/Group Title	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
Arm/Group Description	Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.	Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
All-Cause Mortality
	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/72 (0.00%)	0/69 (0.00%)
Serious Adverse Events
	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/72 (0.00%)	0/69 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Stannous Fluoride Dentifrice	Sodium Monofluorophosphate Dentifrice
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/72 (4.17%)	0/69 (0.00%)
General disorders
Pyrexia	1/72 (1.39%)	0/69 (0.00%)
Infections and infestations
Influenza	1/72 (1.39%)	0/69 (0.00%)
Nervous system disorders
Headache	1/72 (1.39%)	0/69 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02773758
• Other Study ID Numbers: 205201
• First Submitted: May 12, 2016
• First Posted: May 16, 2016
• Results First Submitted: October 17, 2016
• Results First Posted: December 12, 2016
• Last Update Posted: September 29, 2017