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Trial Outcomes & Findings for Effectiveness of Two Water-Based Potassium Oxalate Desensitizers (NCT NCT02192307)

NCT ID: NCT02192307

Last Updated: 2019-11-05

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

60 participants

Primary outcome timeframe

30 days

Results posted on

2019-11-05

Participant Flow

Participant milestones

Participant milestones
Measure
Dipotassium Oxalate Gel
Professional application DiPotassium oxalate
Oxalic Acid Potassium Salt Liquid
Professional application Oxalic Acid Potassium Salt Liquid
Overall Study
STARTED
30
30
Overall Study
COMPLETED
30
30
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Potassium Oxalate Gel
n=30 Participants
Professional application Potassium oxalate gel
Potassium Oxalate Liquid
n=30 Participants
Professional application Potassium oxalate liquid
Total
n=60 Participants
Total of all reporting groups
Age, Continuous
49.5 years
STANDARD_DEVIATION 11.62 • n=5 Participants
45.5 years
STANDARD_DEVIATION 10.82 • n=7 Participants
47.5 years
STANDARD_DEVIATION 11.32 • n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
15 Participants
n=7 Participants
31 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian Indian
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian Oriental
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
10 Participants
n=5 Participants
12 Participants
n=7 Participants
22 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
12 Participants
n=5 Participants
10 Participants
n=7 Participants
22 Participants
n=5 Participants
Race/Ethnicity, Customized
Multiracial
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
30 Participants
n=5 Participants
30 Participants
n=7 Participants
60 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Sixty (60) subjects received study products. Sixty (60) subjects completed the study.

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
Potassium Oxalate Gel
n=30 Participants
Professional application Potassium oxalate
Potassium Oxalate Liquid
n=30 Participants
Professional application Potassium oxalate
Change From Baseline Air Challenge
-0.98 units on a scale
Standard Error 0.38
-0.97 units on a scale
Standard Error 0.47

SECONDARY outcome

Timeframe: 30 Days

Population: Sixty (60) subjects received study products. Sixty (60) subjects completed the study.

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
Potassium Oxalate Gel
n=30 Participants
Professional application Potassium oxalate
Potassium Oxalate Liquid
n=30 Participants
Professional application Potassium oxalate
Change From Baseline Visual Analog Scale
-38.10 units on a scale
Standard Error 27.15
-32.62 units on a scale
Standard Error 23.87

Adverse Events

Potassium Oxalate Gel

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

Potassium Oxalate Liquid

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

Restriction type: OTHER