NCT02152826

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

May 20, 2014

Results QC Date

August 13, 2019

Last Update Submit

August 28, 2020

Conditions

Dentin Sensitivity

Keywords

Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline for 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.

    36 days

Secondary Outcomes (1)

  • Change From Baseline in Dentin Sensitivity

    36 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 oxalateDEVICE

Professional application

Potassium oxalate liquidpotassium oxalate gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, 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

  • Athena Papas, DMD, PhD

    Tufts University School of Dental Medicine

    PRINCIPAL INVESTIGATOR

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

May 20, 2014

First Posted

June 2, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 18, 2020

Results First Posted

September 18, 2020

Record last verified: 2020-08

Locations

US(1)