NCT01115452

Brief Summary

An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

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

September 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

April 30, 2010

Results QC Date

March 21, 2013

Last Update Submit

January 22, 2015

Conditions

Dentine Hypersensitivity

Keywords

potassium nitratetooth sensitivitydentin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution

    Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.

    Baseline and immediately after treatment on Day 5

Secondary Outcomes (15)

  • Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS

    Baseline and immediately after treatment on Day 1

  • Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS

    Baseline and 10 mins post treatment on Day 1

  • Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.

    Baseline and 20 mins post treatment on Day 1

  • Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS

    Baseline and immediately after treatment on Day 2

  • Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS

    Baseline and 10 mins post treatment on Day 2

  • +10 more secondary outcomes

Study Arms (3)

5% KNO3 solution

EXPERIMENTAL

Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.

Drug: 5% Potassium nitrate

2.5% KNO3 solution

EXPERIMENTAL

Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.

Drug: 5% Potassium nitrateDrug: 2.5% Potassium nitrate

Sterile Water

PLACEBO COMPARATOR

Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period.

Other: Sterile water

Interventions

5% Potassium nitrateDRUG

5% potassium nitrate solution

2.5% KNO3 solution5% KNO3 solution
2.5% Potassium nitrateDRUG

2.5% potassium nitrate solution

2.5% KNO3 solution
Sterile waterOTHER

Sterile water

Sterile Water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth
  • Three teeth that can be isolated that meet all of the following criteria at the screening visit:
  • Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3 mm recession at the facial surface midpoint
  • Teeth must be visually stain and calculus free
  • Teeth having a gingival index score of less than or equal to 2
  • Teeth with a clinical mobility less than or equal to 1
  • Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS

You may not qualify if:

  • Chronic disease or other condition that is associated with intermittent episodes of constant daily pain, such as arthritis, low back pain, etc.
  • An condition or medication that causes xerostomia as determined by investigator
  • Sensitive teeth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
  • Teeth with exposed dentine but with deep, defective or facial restorations
  • Teeth used as abutments for fixed or removable partial dentures
  • Teeth with full crowns, orthodontic bands, extensive caries or cracked enamel
  • Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine.
  • Dental prophylaxis within 3 weeks of the screening visit
  • Tongue or lip piercing or presence of dental implants
  • Subjects not using the same brand of toothpaste for at least 4 months prior to the screening visit
  • Subjects who have used desensitizing toothpaste during the 4 weeks before Treatment Visit 1
  • Taking daily dose of medication which may interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquillizers, mood-altering drugs or anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Park Research Center (UPRC)

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 4, 2010

Study Start

September 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 26, 2015

Results First Posted

January 26, 2015

Record last verified: 2015-01

Locations

US(1)