NCT02513212

Brief Summary

This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
5 years until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

July 30, 2015

Results QC Date

August 30, 2019

Last Update Submit

August 28, 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/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)

oxalate liquid, SnF2 paste, manual toothbrush

OTHER

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush

Device: Potassium OxalateDrug: Stannous fluoride pasteDevice: Manual toothbrush

oxalate liquid, SnF2 paste, power toothbrush

OTHER

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

Device: Potassium OxalateDrug: Stannous fluoride pasteDevice: Power toothbrush

Interventions

Potassium OxalateDEVICE

Professionally applied liquid

oxalate liquid, SnF2 paste, manual toothbrushoxalate liquid, SnF2 paste, power toothbrush
Stannous fluoride pasteDRUG

SnF2 Paste

oxalate liquid, SnF2 paste, manual toothbrushoxalate liquid, SnF2 paste, power toothbrush
Manual toothbrushDEVICE

Marketed manual toothbrush

oxalate liquid, SnF2 paste, manual toothbrush
Power toothbrushDEVICE

Marketed power toothbrush

oxalate liquid, SnF2 paste, power toothbrush

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 photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
  • be in good general health as determined by the Investigator/designee; and
  • have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool 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;
  • any diseases or conditions that might interfere with the safe completion of the study; or
  • 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

Publication Agreements

PI is Sponsor Employee
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 30, 2015

First Posted

July 31, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Locations

US(1)