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

• Sponsor: Procter and Gamble (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02513212
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Device: Potassium Oxalate; Drug: Stannous fluoride paste; Device: Manual toothbrush; Device: Power toothbrush	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: oxalate liquid, SnF2 paste, manual toothbrush Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush	Device: Potassium Oxalate; Professionally applied liquid; Drug: Stannous fluoride paste; SnF2 Paste; Device: Manual toothbrush; Marketed manual toothbrush
Other: oxalate liquid, SnF2 paste, power toothbrush Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush	Device: Potassium Oxalate; Professionally applied liquid; Drug: Stannous fluoride paste; SnF2 Paste; Device: Power toothbrush; Marketed power toothbrush

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Air Challenge [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.

Secondary Outcome Measures

1. Change From Baseline Visual Analog Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• be at least 18 years of age;

• provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;

• be in good general health as determined by the Investigator/designee; and

• have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.

Exclusion Criteria:

• self-reported pregnancy or nursing;

• severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;

• active treatment of periodontitis;

• any diseases or conditions that might interfere with the safe completion of the study; or

• an inability to undergo any study procedures.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chad J Anderson DMD Inc	Fresno	California	United States	93730

Sponsors and Collaborators

• Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT02513212
• Other Study ID Numbers: 2015059
• First Posted: Jul 31, 2015
• Last Update Posted: Aug 31, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Procter and Gamble: Sensitivity
• Additional relevant MeSH terms: Dentin Sensitivity; Hypersensitivity; Fluorides; Tin Fluorides

Study Results

Participant Flow

Arm/Group Title	Oxalate Liquid, SnF2 Paste, Manual Toothbrush	Oxalate Liquid, SnF2 Paste, Power Toothbrush
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	12	12
COMPLETED	11	12
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Oxalate Liquid, SnF2 Paste, Manual Toothbrush	Oxalate Liquid, SnF2 Paste, Power Toothbrush	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.6 (14.74)	46.7 (9.63)	44.6 (12.36)
Sex: Female, Male (Count of Participants)
Female	10 83.3%	12 100%	22 91.7%
Male	2 16.7%	0 0%	2 8.3%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	7 58.3%	8 66.7%	15 62.5%
Black	1 8.3%	0 0%	1 4.2%
Asian Oriental	2 16.7%	1 8.3%	3 12.5%
Multi-Racial	1 8.3%	1 8.3%	2 8.3%
Hispanic	1 8.3%	2 16.7%	3 12.5%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Air Challenge
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxalate Liquid, SnF2 Paste, Manual Toothbrush	Oxalate Liquid, SnF2 Paste, Power Toothbrush
Arm/Group Description	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	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
Measure Participants	11	12
Mean (Standard Deviation) [Units on a scale]	-0.409 (0.701)	-0.917 (0.733)

2. Secondary Outcome

Title	Change From Baseline Visual Analog Scale
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxalate Liquid, SnF2 Paste, Manual Toothbrush	Oxalate Liquid, SnF2 Paste, Power Toothbrush
Arm/Group Description	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	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
Measure Participants	11	12
Mean (Standard Deviation) [Units on a scale]	-11.000 (12.929)	-28.500 (21.075)

Adverse Events

Arm/Group Title	Oxalate Liquid, SnF2 Paste, Manual Toothbrush		Oxalate Liquid, SnF2 Paste, Power Toothbrush
Arm/Group Description	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		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
All Cause Mortality
	Oxalate Liquid, SnF2 Paste, Manual Toothbrush		Oxalate Liquid, SnF2 Paste, Power Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Oxalate Liquid, SnF2 Paste, Manual Toothbrush		Oxalate Liquid, SnF2 Paste, Power Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Oxalate Liquid, SnF2 Paste, Manual Toothbrush		Oxalate Liquid, SnF2 Paste, Power Toothbrush
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.