MedDataX Logo

Trial Outcomes & Findings for A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes (NCT NCT02513212)

NCT ID: NCT02513212

Last Updated: 2020-08-31

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/subject responds to stimulus and requests discontinuation or moves form 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

NA

Target enrollment

24 participants

Primary outcome timeframe

30 days

Results posted on

2020-08-31

Participant Flow

Participant milestones

Participant milestones
Measure
Oxalate Liquid, SnF2 Paste, Manual Toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush
Oxalate Liquid, SnF2 Paste, Power Toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush
Overall Study
STARTED
12
12
Overall Study
COMPLETED
11
12
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Oxalate Liquid, SnF2 Paste, Manual Toothbrush
n=12 Participants
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush
Oxalate Liquid, SnF2 Paste, Power Toothbrush
n=12 Participants
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush
Total
n=24 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
42.6 years
STANDARD_DEVIATION 14.74 • n=5 Participants
46.7 years
STANDARD_DEVIATION 9.63 • n=7 Participants
44.6 years
STANDARD_DEVIATION 12.36 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
12 Participants
n=7 Participants
22 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Caucasian
7 Participants
n=5 Participants
8 Participants
n=7 Participants
15 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Black
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Asian Oriental
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Multi-Racial
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Hispanic
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
12 participants
n=7 Participants
24 participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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/subject responds to stimulus and requests discontinuation or moves form 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.

Outcome measures

Outcome measures
Measure
Oxalate Liquid, SnF2 Paste, Manual Toothbrush
n=11 Participants
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush
Oxalate Liquid, SnF2 Paste, Power Toothbrush
n=12 Participants
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush
Change From Baseline Air Challenge
-0.409 Units on a scale
Standard Deviation 0.701
-0.917 Units on a scale
Standard Deviation 0.733

SECONDARY outcome

Timeframe: 30 days

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, SnF2 Paste, Manual Toothbrush
n=11 Participants
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush
Oxalate Liquid, SnF2 Paste, Power Toothbrush
n=12 Participants
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush
Change From Baseline Visual Analog Scale
-11.000 Units on a scale
Standard Deviation 12.929
-28.500 Units on a scale
Standard Deviation 21.075

Adverse Events

Oxalate Liquid, SnF2 Paste, Manual Toothbrush

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Oxalate Liquid, SnF2 Paste, Power Toothbrush

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Manager

The Procter & Gamble Company

Phone: 513-622-2489

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place