Trial Outcomes & Findings for Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity (NCT NCT02613117)

NCT ID: NCT02613117

Last Updated: 2020-09-22

Results Overview

Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: up to 8 weeks
• Results posted on: 2020-09-22

Participant Flow

Participant milestones

Measure	Potassium Oxalate Gel potassium oxalate gel self applied Potassium Oxalate Gel: Self applied	Oxalate Liquid, SnF2 Paste Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste
Overall Study STARTED	57	47
Overall Study COMPLETED	57	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity

Baseline characteristics by cohort

Measure	Potassium Oxalate Gel n=57 Participants potassium oxalate gel self applied Potassium Oxalate Gel: Self applied	Oxalate Liquid, SnF2 Paste n=47 Participants Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste	Total n=104 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 11.99 • n=5 Participants	45.8 years STANDARD_DEVIATION 12.91 • n=7 Participants	43.6 years STANDARD_DEVIATION 12.51 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	47 participants n=7 Participants	104 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 weeks

Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

Outcome measures

Measure	Potassium Oxalate Gel n=56 Participants potassium oxalate gel self applied Potassium Oxalate Gel: Self applied	Oxalate Liquid, SnF2 Paste n=44 Participants Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste
How Satisfied Were Participants With Treatment? Very Dissatisfied	0 Participants	1 Participants
How Satisfied Were Participants With Treatment? Somewhat Dissatisfied	2 Participants	2 Participants
How Satisfied Were Participants With Treatment? Neutral	7 Participants	11 Participants
How Satisfied Were Participants With Treatment? Somewhat Satisfied	23 Participants	10 Participants
How Satisfied Were Participants With Treatment? Very Satisfied	24 Participants	20 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

Outcome measures

Measure	Potassium Oxalate Gel n=56 Participants potassium oxalate gel self applied Potassium Oxalate Gel: Self applied	Oxalate Liquid, SnF2 Paste n=44 Participants Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste
Ease of Treatment at Home Extremely Easy to Use	29 Participants	30 Participants
Ease of Treatment at Home Extremely Difficult to Use	0 Participants	0 Participants
Ease of Treatment at Home Somewhat Difficult to Use	1 Participants	0 Participants
Ease of Treatment at Home Neither Easy Nor Difficult to Use	2 Participants	12 Participants
Ease of Treatment at Home Somewhat Easy to Use	24 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.

Outcome measures

Measure	Potassium Oxalate Gel n=56 Participants potassium oxalate gel self applied Potassium Oxalate Gel: Self applied	Oxalate Liquid, SnF2 Paste n=44 Participants Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste
Did Participants Notice a Difference in the Areas Noted? Hot/Cold · Yes	42 Participants	30 Participants
Did Participants Notice a Difference in the Areas Noted? Other · No	48 Participants	35 Participants
Did Participants Notice a Difference in the Areas Noted? Hot/Cold · No	14 Participants	14 Participants
Did Participants Notice a Difference in the Areas Noted? Sweet/Sour · Yes	19 Participants	9 Participants
Did Participants Notice a Difference in the Areas Noted? Sweet/Sour · No	37 Participants	35 Participants
Did Participants Notice a Difference in the Areas Noted? Hard/Soft · Yes	7 Participants	13 Participants
Did Participants Notice a Difference in the Areas Noted? Hard/Soft · No	49 Participants	31 Participants
Did Participants Notice a Difference in the Areas Noted? Cold Air · Yes	28 Participants	18 Participants
Did Participants Notice a Difference in the Areas Noted? Cold Air · No	28 Participants	26 Participants
Did Participants Notice a Difference in the Areas Noted? Other · Yes	8 Participants	9 Participants

Adverse Events

Potassium Oxalate Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxalate Liquid, SnF2 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

Adverse event data not reported

Additional Information

Clinical Trial Manager

Procter and Gamble

Phone: 513-622-2489

Email: peters.j.2@pg.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI should disclose plans to sponsor prior to public release.
• Publication restrictions are in place

Restriction type: OTHER