Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity (NCT NCT02189382)

Last Updated: 2018-08-20

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

Target enrollment

70 participants

Primary outcome timeframe

30 days

Results posted on

2018-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Potassium Oxalate Gel Self Applied Potassium Oxalate	Water Self Applied Water
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Potassium Oxalate Gel n=35 Participants Self Applied Potassium Oxalate	Water n=35 Participants Self Applied Water	Total n=70 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 11.13 • n=93 Participants	36.6 years STANDARD_DEVIATION 14.25 • n=4 Participants	35.6 years STANDARD_DEVIATION 12.74 • n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	22 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity · Asian Indian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity · Asian Oriental	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity · Black	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	9 Participants n=93 Participants	6 Participants n=4 Participants	15 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity · Multi-Racial	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Potassium Oxalate Gel n=35 Participants Self Applied Potassium Oxalate	Water n=35 Participants Self Applied Water
Change From Baseline Air Challenge	-1.200 units on a scale Standard Deviation 0.677	-0.086 units on a scale Standard Deviation 0.284

SECONDARY outcome

Timeframe: 30 days

Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.

Outcome measures

Outcome measures
Measure	Potassium Oxalate Gel n=35 Participants Self Applied Potassium Oxalate	Water n=35 Participants Self Applied Water
Change From Baseline in Tactile Threshold	16.857 Grams (g) Standard Deviation 12.312	0.286 Grams (g) Standard Deviation 2.956

Adverse Events

Potassium Oxalate Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

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

Procter and Gamble

Phone: 513-622-2489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Written consent from sponsor.
Publication restrictions are in place

Restriction type: OTHER