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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189382
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dentin Sensitivity
Interventions Device: Potassium Oxalate
Other: Water
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Potassium Oxalate Gel Water
Hide Arm/Group Description

Self Applied

Potassium Oxalate

Self Applied

Water

Period Title: Overall Study
Started 35 35
Completed 35 35
Not Completed 0 0
Arm/Group Title Potassium Oxalate Gel Water Total
Hide Arm/Group Description

Self Applied

Potassium Oxalate

Self Applied

Water

Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
34.5  (11.13) 36.6  (14.25) 35.6  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
20
  57.1%
22
  62.9%
42
  60.0%
Male
15
  42.9%
13
  37.1%
28
  40.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 35 participants 35 participants 70 participants
Asian Indian
0
   0.0%
1
   2.9%
1
   1.4%
Asian Oriental
2
   5.7%
1
   2.9%
3
   4.3%
Black
10
  28.6%
10
  28.6%
20
  28.6%
Caucasian
12
  34.3%
14
  40.0%
26
  37.1%
Hispanic
9
  25.7%
6
  17.1%
15
  21.4%
Multi-Racial
2
   5.7%
3
   8.6%
5
   7.1%
1.Primary Outcome
Title Change From Baseline Air Challenge
Hide 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/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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Potassium Oxalate Gel Water
Hide Arm/Group Description:

Self Applied

Potassium Oxalate

Self Applied

Water

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.200  (0.677) -0.086  (0.284)
2.Secondary Outcome
Title Change From Baseline in Tactile Threshold
Hide Description Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Potassium Oxalate Gel Water
Hide Arm/Group Description:

Self Applied

Potassium Oxalate

Self Applied

Water

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: Grams (g)
16.857  (12.312) 0.286  (2.956)
Time Frame 30 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Potassium Oxalate Gel Water
Hide Arm/Group Description

Self Applied

Potassium Oxalate

Self Applied

Water

All-Cause Mortality
Potassium Oxalate Gel Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Hide Serious Adverse Events
Potassium Oxalate Gel Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Potassium Oxalate Gel Water
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Written consent from sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Manager
Organization: Procter and Gamble
Phone: 513-622-2489
EMail: peters.j.2@pg.com
Layout table for additonal information
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02189382    
Other Study ID Numbers: 2014029
First Submitted: July 8, 2014
First Posted: July 14, 2014
Results First Submitted: May 9, 2018
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018