A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

• Sponsor: Procter and Gamble (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02221349
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief Summary

This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Device: Potassium oxalate; Drug: Sodium fluoride paste; Drug: Stannous fluoride paste	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: oxalate liquid & gel plus SnF2 paste Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied	Device: Potassium oxalate; Professionally applied (liquid) and self applied (gel); Drug: Stannous fluoride paste; Toothpaste used by subject; Other Names: SnF2 paste
Other: oxalate liquid & gel plus NaF paste Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied	Device: Potassium oxalate; Professionally applied (liquid) and self applied (gel); Drug: Sodium fluoride paste; Toothpaste used by subject; Other Names: NaF paste

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Air Challenge [60 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/subjects responds to stimulus and requests discontinuation or moves from 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 [60 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 confidentiality disclosure agreement

• Be in good general health as determined by the Investigator/designee

• Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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

• Fixed facial orthodontic appliances

• A history of kidney stones

• Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

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

• 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

• Principal Investigator: Chad J Anderson, MS, DMD, Chad J Anderson DMD Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT02221349
• Other Study ID Numbers: 2014069
• First Posted: Aug 20, 2014
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 1, 2020

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

Study Results

Participant Flow

Arm/Group Title	Oxalate Liquid & Gel Plus SnF2 Paste	Oxalate Liquid & Gel Plus NaF Paste
Arm/Group Description	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	15
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Oxalate Liquid & Gel Plus SnF2 Paste	Oxalate Liquid & Gel Plus NaF Paste	Total
Arm/Group Description	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.5 (10.97)	44.9 (12.52)	43.2 (11.69)
Sex: Female, Male (Count of Participants)
Female	14 93.3%	14 93.3%	28 93.3%
Male	1 6.7%	1 6.7%	2 6.7%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	1 6.7%	2 13.3%	3 10%
American Indian	0 0%	1 6.7%	1 3.3%
Asian Oriental	2 13.3%	0 0%	2 6.7%
Black	2 13.3%	0 0%	2 6.7%
Caucasian	10 66.7%	11 73.3%	21 70%
Multi-Racial	0 0%	1 6.7%	1 3.3%

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/subjects responds to stimulus and requests discontinuation or moves from 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	60 days

Outcome Measure Data

Analysis Population Description

Thirty (30) subjects received study products and were measured at the Baseline visit. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.

Arm/Group Title	Oxalate Liquid & Gel Plus SnF2 Paste	Oxalate Liquid & Gel Plus NaF Paste
Arm/Group Description	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Measure Participants	14	15
Mean (Standard Deviation) [Units on a scale]	-1.643 (0.770)	-1.500 (0.906)

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	60 days

Outcome Measure Data

Analysis Population Description

Thirty (30) subjects received study products. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.

Arm/Group Title	Oxalate Liquid & Gel Plus SnF2 Paste	Oxalate Liquid & Gel Plus NaF Paste
Arm/Group Description	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
Measure Participants	14	15
Mean (Standard Deviation) [Units on a scale]	-29.82 (18.65)	-24.67 (26.75)

Adverse Events

Arm/Group Title	Oxalate Liquid & Gel Plus SnF2 Paste		Oxalate Liquid & Gel Plus NaF Paste
Arm/Group Description	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Stannous fluoride paste: Toothpaste used by subject		Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Potassium oxalate: Professionally applied (liquid) and self applied (gel) Sodium fluoride paste: Toothpaste used by subject
All Cause Mortality
	Oxalate Liquid & Gel Plus SnF2 Paste		Oxalate Liquid & Gel Plus NaF Paste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		0/15 (0%)
Serious Adverse Events
	Oxalate Liquid & Gel Plus SnF2 Paste		Oxalate Liquid & Gel Plus NaF Paste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Oxalate Liquid & Gel Plus SnF2 Paste		Oxalate Liquid & Gel Plus NaF Paste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		0/15 (0%)
Gastrointestinal disorders
Hyperesthesia	1/14 (7.1%)	2	0/15 (0%)	0
PAIN	1/14 (7.1%)	1	0/15 (0%)	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.