Trial Outcomes & Findings for Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis (NCT NCT02481557)

Last Updated: 2019-06-11

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. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

10 Minutes

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Oxalate Salt Solution Professionally applied Oxalate Salt Solution: Applied by dentist	No Treatment No study treatment
Overall Study STARTED	17	19
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxalate Salt Solution n=17 Participants Professionally applied Oxalate Salt Solution: Applied by dentist	No Treatment n=19 Participants No Treatment	Total n=36 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 14.14 • n=5 Participants	34.5 years STANDARD_DEVIATION 10.11 • n=7 Participants	34.5 years STANDARD_DEVIATION 12.00 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian Oriental	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Multi-Racial	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 Minutes

Population: Thirty-Six (36) subjects received products. Thirty-Six (36) subjects completed the study.

Outcome measures

Outcome measures
Measure	Oxalate Salt Solution n=17 Participants Professionally applied Oxalate Salt Solution: Applied by dentist	No Treatment n=19 Participants No Treatment
Change From Baseline Air Challenge	-0.412 Units on a scale Standard Deviation 0.537	-0.132 Units on a scale Standard Deviation 0.403

SECONDARY outcome

Timeframe: 10 Minutes

Population: Thirty-six (36) subjects received study products. Thirty-six (36) subjects completed the study.

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	Oxalate Salt Solution n=17 Participants Professionally applied Oxalate Salt Solution: Applied by dentist	No Treatment n=19 Participants No Treatment
Change From Baseline for Yeaple Probe	10.000 Units on a scale Standard Deviation 8.101	1.316 Units on a scale Standard Deviation 6.634

Adverse Events

Oxalate Salt Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place