Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

NCT02189382 | Completed Results DMC

• 1 other identifier: 2014029
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on 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 in Tactile Threshold

  30 days

Study Arms (2)

Potassium Oxalate Gel

EXPERIMENTAL

Self Applied

Device: Potassium Oxalate

Water

OTHER

Self Applied

Other: Water

Interventions

Potassium Oxalate DEVICE

Potassium Oxalate Gel

Water OTHER

Water

Eligibility Criteria

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

You may qualify if:

• 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;
• agree not to participate in any other oral/dental product studies during the course of this study;
• agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
• agree to refrain from the use of any non-study oral hygiene products;
• agree to return for all scheduled visits and follow study procedures; and.
• have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge

You may not qualify if:

• 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; or
• an inability to undergo any study procedures.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Interventions

Water

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter and Gamble

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 14, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2018-07

Locations

US (1)