Trial Outcomes & Findings for A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene (NCT NCT02221349)

Last Updated: 2020-09-09

Results Overview

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

60 days

Results posted on

2020-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Oxalate Liquid & Gel Plus SnF2 Paste Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Oxalate Liquid & Gel Plus NaF Paste Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Overall Study STARTED	15	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxalate Liquid & Gel Plus SnF2 Paste n=15 Participants Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Oxalate Liquid & Gel Plus NaF Paste n=15 Participants Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	41.5 years STANDARD_DEVIATION 10.97 • n=93 Participants	44.9 years STANDARD_DEVIATION 12.52 • n=4 Participants	43.2 years STANDARD_DEVIATION 11.69 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized American Indian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian Oriental	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Black	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Multi-Racial	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 60 days

Population: Thirty (30) subjects received study products and were measured at the Baseline visit. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.

Outcome measures

Outcome measures
Measure	Oxalate Liquid & Gel Plus SnF2 Paste n=14 Participants Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Oxalate Liquid & Gel Plus NaF Paste n=15 Participants Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Change From Baseline Air Challenge	-1.643 Units on a scale Standard Deviation 0.770	-1.500 Units on a scale Standard Deviation 0.906

SECONDARY outcome

Timeframe: 60 days

Population: Thirty (30) subjects received study products. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.

Outcome measures

Outcome measures
Measure	Oxalate Liquid & Gel Plus SnF2 Paste n=14 Participants Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Oxalate Liquid & Gel Plus NaF Paste n=15 Participants Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Change From Baseline Visual Analog Scale	-29.82 Units on a scale Standard Deviation 18.65	-24.67 Units on a scale Standard Deviation 26.75

Adverse Events

Oxalate Liquid & Gel Plus SnF2 Paste

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Oxalate Liquid & Gel Plus NaF Paste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxalate Liquid & Gel Plus SnF2 Paste n=14 participants at risk Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Oxalate Liquid & Gel Plus NaF Paste n=15 participants at risk Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Gastrointestinal disorders Hyperesthesia	7.1% 1/14 • Number of events 2	0.00% 0/15
Gastrointestinal disorders PAIN	7.1% 1/14 • Number of events 1	0.00% 0/15

Additional Information

Clinical Trial Manager

The Procter & Gamble Company

Phone: 513-622-2489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place