Dose Response of a Tubule Occlusion Agent

NCT01075256 | Completed Phase 4 Results

• 1 other identifier: Z3690607
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity

Conditions

Dentine Hypersensitivity; Dental Pain

Keywords

sensitivity; occlusion

Outcome Measures

Primary Outcomes (2)

• Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15

  Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.

  Baseline to Day 15

• Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15

  Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.

  Baseline to Day 15

Secondary Outcomes (2)

• Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7

  Baseline to Day 7

• Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7

  Baseline to Day 7

Other Outcomes (4)

• Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10

  Baseline to Day 10

• Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10

  Baseline to Day 10

• Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3

  Baseline to Day 3

Study Arms (3)

5% calcium sodium phosphosilicate toothpaste

ACTIVE COMPARATOR

Participants to brush their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste.

Device: 5% calcium sodium phosphosilicate toothpaste

7.5% calcium sodium phosphosilicate toothpaste

ACTIVE COMPARATOR

Participants to brush their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste.

Device: 7.5% calcium sodium phosphosilicate toothpaste

Placebo toothpaste

PLACEBO COMPARATOR

Participants to brush their teeth for two minutes, twice daily for 15 days with placebo toothpaste.

Device: Placebo toothpaste

Interventions

5% calcium sodium phosphosilicate toothpaste DEVICE

Low concentration calcium sodium phosphosilicate tubule occlusion agent

5% calcium sodium phosphosilicate toothpaste

7.5% calcium sodium phosphosilicate toothpaste DEVICE

High concentration calcium sodium phosphosilicate tubule occlusion agent

7.5% calcium sodium phosphosilicate toothpaste

Placebo toothpaste DEVICE

Placebo toothpaste

Placebo toothpaste

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Age: Aged between 20 - 50 years.
• General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
• Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
• Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion, abrasion and/or gingival recession.
• Gingival Health / Tooth Mobility Grade:Study teeth must have Löe and Silness Gingival Index (GI) score less than or equal to 2 and clinical mobility less than or equal to grade I.
• Current Product Use: Participants must have been using the same brand of toothpaste for at least 2 months and should not have used desensitizing toothpaste during the 4 weeks preceding screening. Participants will be required to bring in their current toothpaste(s) in order to verify the ingredients.
• VAS Training: Successfully completes the VAS training exercise at Screening.
• Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.

You may not qualify if:

• Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Breast-feeding: Women who are breast-feeding.
• Medical History: a) Chronic debilitating disease is present b)Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc.
• Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs.
• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Previous participation in this study.
• Xerostomia: Any condition or medication that causes xerostomia.
• Personnel: An employee of the sponsor or the study site or members of their immediate family.
• Other: Any subject who in the opinion of the investigator, should not participate in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

University Park Research Center (UPRC)

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity; Toothache; Hypersensitivity; Bites and Stings

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Limitations and Caveats

An issue with study product packaging was discovered post-study completion. The nature indicated that subject response was likely to have been liable to a positive bias. Efficacy cannot be considered as valid and no reliable conclusions possible.

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 3, 2013
• Results First Posted: June 3, 2013

Record last verified: 2013-04

Locations

US (1)