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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Device: Potassium Oxalate; Drug: Stannous fluoride paste; Device: Manual toothbrush; Device: Power toothbrush

• Registration Number: NCT02513212
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2019-08-30
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Results First Posted: 2020-08-31
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxalate liquid, SnF2 paste, manual toothbrush	Potassium Oxalate	Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
oxalate liquid, SnF2 paste, manual toothbrush	Stannous fluoride paste	Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
oxalate liquid, SnF2 paste, power toothbrush	Stannous fluoride paste	Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
oxalate liquid, SnF2 paste, manual toothbrush	Manual toothbrush	Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
oxalate liquid, SnF2 paste, power toothbrush	Potassium Oxalate	Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
oxalate liquid, SnF2 paste, power toothbrush	Power toothbrush	Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Chad J Anderson DMD Inc; 🇺🇸 Fresno, California, United States