NCT02221349

Brief Summary

This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

August 12, 2014

Results QC Date

August 30, 2019

Last Update Submit

September 8, 2020

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/subjects responds to stimulus and requests discontinuation or moves from 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.

    60 days

Secondary Outcomes (1)

  • Change From Baseline Visual Analog Scale

    60 days

Study Arms (2)

oxalate liquid & gel plus SnF2 paste

OTHER

Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied

Device: Potassium oxalateDrug: Stannous fluoride paste

oxalate liquid & gel plus NaF paste

OTHER

Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied

Device: Potassium oxalateDrug: Sodium fluoride paste

Interventions

Stannous fluoride pasteDRUG

Toothpaste used by subject

Also known as: SnF2 paste
oxalate liquid & gel plus SnF2 paste
Potassium oxalateDEVICE

Professionally applied (liquid) and self applied (gel)

oxalate liquid & gel plus NaF pasteoxalate liquid & gel plus SnF2 paste
Sodium fluoride pasteDRUG

Toothpaste used by subject

Also known as: NaF paste
oxalate liquid & gel plus NaF paste

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air 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
  • An inability to undergo any study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chad J Anderson DMD Inc

Fresno, California, 93730, United States

Location

MeSH Terms

Conditions

Dentin SensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesImmune System Diseases

Results Point of Contact

Title
Clinical Trial Manager
Organization
The Procter & Gamble Company
peters.j.2@pg.com
513-622-2489

Study Officials

  • Chad J Anderson, MS, DMD

    Chad J Anderson DMD Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
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

August 12, 2014

First Posted

August 20, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 9, 2020

Results First Posted

September 9, 2020

Record last verified: 2020-09

Locations

US(1)