Dose Response of a Tubule Occlusion Agent

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

Detailed Description
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Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine typically in response to chemical, thermal, tactile or osmotic stimuli. Dentine hypersensitivity may be treated by either making the nerve in the tooth less sensitive or by occluding the tubules to limit exposure of the nerve to external stimuli. Bioactive and biocompatible glasses react with oral fluid to deposit a mineral that is chemically analogous to that found in both enamel and dentine thus preventing exposure of the nerve to external stimuli. A number of controlled clinical trials have been reported indicating that a calcium sodium phosphosilicate bioactive glass, when incorporated into a toothpaste formulation, significantly reduce pain from dentine hypersensitivity. The aim of this study is to evaluate the effectiveness of two currently marketed toothpastes, containing 5% calcium sodium phosphosilicate and the other containing 7.5% calcium sodium phosphosilicate in the treatment of dentine hypersensitivity compared to a matched placebo control.

Official Title
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An Exploratory Clinical Study to Evaluate the Efficacy of Two Currently Marketed Toothpastes Containing Different Concentrations of a Tubule Occlusion Agent

Conditions
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Dentine Hypersensitivity, Dental Pain

Intervention / Treatment
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* Device: 5% calcium sodium phosphosilicate toothpaste
* Device: 7.5% calcium sodium phosphosilicate toothpaste
* Device: Placebo toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Sensitivity: Self-reported history of dentinal hypersensitivity and a primary complaint of sensitive teeth lasting a maximum of 10 years. At Screening: A minimum of 5 evaporative (air) sensitive lateral incisors, canines or pre-molars must display a response greater than 25 mm on a 100 mm VAS. At Baseline: A minimum of 3 of the 5 evaporative (air) sensitive teeth identified at screening must display a response greater than 25 mm on a 100 mm VAS. All teeth meeting the sensitivity Inclusion Criteria will be followed and assessed using both efficacy parameters. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions. Exclusion Criteria: 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. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter (OTC) dentifrice in the opinion of the investigator. b) 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 aetiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5% calcium sodium phosphosilicate toothpaste<br>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<br>* Low concentration calcium sodium phosphosilicate tubule occlusion agent<br>|
| Active Comparator: 7.5% calcium sodium phosphosilicate toothpaste<br>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<br>* High concentration calcium sodium phosphosilicate tubule occlusion agent<br>|
| Placebo Comparator: Placebo toothpaste<br>Participants to brush their teeth for two minutes, twice daily for 15 days with placebo toothpaste. | Device: Placebo toothpaste<br>* Placebo toothpaste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7 | 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 7 | 
| Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7 | 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 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensitivity, occlusion