Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

NCT02192307 | Completed Results

• 1 other identifier: 2014047
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dentin Sensitivity

Keywords

Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Air Challenge

  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.

  30 days

Secondary Outcomes (1)

• Change From Baseline Visual Analog Scale

  30 Days

Study Arms (2)

potassium oxalate gel

EXPERIMENTAL

Professional application

Device: Potassium oxalate

Potassium oxalate liquid

ACTIVE COMPARATOR

Professional application

Device: Potassium oxalate

Interventions

Potassium oxalate DEVICE

Also known as: Professional application

Potassium oxalate liquid; potassium oxalate gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: The Procter & Gamble Company

peters.j.2@pg.com

513-622-2489

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 5, 2019
• Results First Posted: November 5, 2019

Record last verified: 2019-10

Locations

US (1)