Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Device: Potassium oxalate

• Registration Number: NCT02152826
• Lead Sponsor: Procter and Gamble

Brief Summary

This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2019-08-13
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Results First Posted: 2020-09-18
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Provide written informed consent to participate in the study
• Be at least 18 years of age
• Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
• Agree to refrain from participating in any other oral/dental product studies for the duration of the study
• Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
• Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
• Agree to comply with study/product usage instructions; and
• Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria

• Gross oral neglect or urgent dental treatment needs
• Severe periodontal disease and/or generalized mobility
• Active treatment for periodontitis
• Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
• Self-reported pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
potassium oxalate gel	Potassium oxalate	Professional application
Potassium oxalate liquid	Potassium oxalate	Professional application

Primary Outcome Measures

Name	Time	Method
Change From Baseline for Air Challenge	36 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 in Dentin Sensitivity	36 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)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States