Colgate<sup>®</sup> Sensitive Pre-Procedural Desensitizing Paste™ (Rx, In-office Treatment)

Colgate® Sensitive Pre-Procedural Desensitizing Paste™ (Rx, In-office Treatment)

Clinically proven to provide rapid dentin hypersensitivity relief1

Reference:

1. Schiff T, et al. Am J Dent.
2009;22(Spec Iss A):8A-15A.

Ingredients

Active ingredients

Arginine 8%

Inactive ingredients

Hydrated Silica, Calcium Carbonate, Glycerin, Water, Bicarbonate, Flavor, Cellulose Gum, Sodium Saccharin, FD&C Blue No. 1.

Mode Of Action

Colgate® Sensitive Pre-Procedural Desensitizing Paste with Pro-Argin Technology plugs and seals exposed dentine tubules.

Proof of Efficacy

Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity.
Schiff T, Delgado E, Zhang YP, Cummins D, DeVizio W, Mateo LR

Study objectives:
The objectives of the study were
1. to compare the efficacy of 2 in-office pastes in reducing dentin hypersensitivity immediately after a single application following dental scaling, and
2. to assess the duration of relief over a period of 4 and 12 weeks.

Trial conditions and methods

Products under investigation
Test: Colgate® Sensitive Pre-Procedural Desensitizing Paste (Colgate-Palmolive Company, New York, NY) containing 8% arginine in a calcium carbonate/silica base.
Control: Nupro pumice-based fluoride-free prophylaxis paste (Dentsply, York, PA).

Study subjects
A total of 68 male and female subjects (aged between 24 and 56 years) with established dentin hypersensitivity (2 hypersensitive teeth with a tactile sensitivity score [Yeaple probe] of 10-50 grams of force, and an air blast score of 2 or 3 on the Schiff Cold-Air Sensitivity Scale).

Methods In this double-blind, parallel group study, 68 subjects with established dentin hypersensitivity were randomly assigned to either the test (n=32) or control (n=36) group. Following baseline evaluation of dentin hypersensitivity, subjects received a professional dental scaling, after which tactile and air blast sensitivity scores were determined. The assigned in-office paste was then applied as the final polishing step of the professional cleaning procedure. Tactile and air-blast sensitivity scores were determined immediately after product application.
Subjects then brushed twice daily with a commercial fluoride anti-cavity toothpaste and a soft bristled toothbrush for 12 weeks. Dentin hypersensitivity scores were determined after 4 and 12 weeks. Statistical analyses were performed separately for tactile and air-blast scores. Within treatment comparisons were performed using a T-test. Comparisons between treatments using baseline adjusted scores were performed using analysis of covariance (ANCOVA).
Results and Conclusion

Results
No statistically significant differences from baseline scores were indicated at the post-scaling examination between the 2 groups. Immediately post-product application and after 4 weeks, subjects assigned to the test product demonstrated statistically significant improvements from baseline in tactile (156.2% and 170.3%, respectively) and air-blast (44.1% and 45.9%, respectively) sensitivity scores. At the same time points, subjects assigned to the control product demonstrated statistically significant improvements from baseline in tactile (43.1% and 8.3%, respectively) and air-blast (15.1% and 8.9%, respectively) sensitivity scores.
Immediately post-product application and after 4 weeks, the test product group demonstrated statistically significant improvements compared to the control group in tactile (79.0% and 149.6%, respectively) and air-blast (34.1% and 40.6%, respectively) sensitivity scores. No statistically significant differences between test and control groups were indicated at the post-scaling and 12-week examinations.

Conclusion
Colgate® Sensitive Pro-Relief Desensitizing Paste provides a statistically significant reduction in dentin hypersensitivity as compared to a control prophylaxis paste immediately after a single application following dental scaling. This relief lasts for 4 weeks.

Directions for Use

1. Place enough paste for 1 procedure in a clean dampened dish or other suitable container (when dispensing from tube).
2. Fill a rotary cup with paste, and run rotary cup at low-to-moderate speed.
3. Polish product into each tooth, on sensitive areas, or areas that can become sensitive (can be applied to entire dentition). Apply product to sensitive areas for 3 seconds, then repeat.

NOTE: Throughout procedure, sufficient paste should be maintained on the cup to avoid overheating of the tooth surface. Saliva evacuation is recommended to avoid excess dilution and swallowing of the paste.

Prescribing Information

Description

Colgate® Sensitive Pre-Procedural Desensitizing Paste is a desensitizing paste that provides instant sensitivity relief after 1 application. The Pro-Argin Technology effectively plugs and seals open dentin tubules when polished into teeth with a rotary cup.

Composition

Colgate® Sensitive Pre-Procedural Desensitizing Paste contains hydrated silica, calcium carbonate, glycerin, arginine, water, bicarbonate, flavor, cellulose gum, sodium saccharin, FD&C blue no.1.

Indications and Usage

Colgate® Sensitive Pre-Procedural Desensitizing Paste is to be used for the management of sensitive teeth, post scaling and root planing. It is a tubule occluding agent designed for professional application with a rotary cup during standard dental practice hygiene procedures.

Dosage

To be determined by the dental professional for the treatment of dentin hypersensitivity.

Directions for Use

  • Place enough paste for one procedure in a clean dappen dish or other suitable container (when dispensing from tube).
  • Fill a rotary cup with paste and run rotary cup at low to moderate speed.
  • Polish product into each tooth, on sensitive areas or areas that can become sensitive (can be applied to entire dentition). Apply product to sensitive areas for 3 seconds, then repeat.

NOTE: Throughout procedure, sufficient paste should be maintained on the cup to avoid overheating of the tooth surface. Saliva evacuation is recommended to avoid excess dilution and swallowing of the paste.

Contraindications

Colgate® Sensitive Pre-Procedural Desensitizing Paste is contraindicated in patients with a known allergy to any of the components.

Warnings

Colgate® Sensitive Pre-Procedural Desensitizing Paste may cause eye irritation upon contact. If contact with eyes occurs, immediately flush eyes with plenty of water for 15 minutes. Seek medical attention if irritation or discomfort persists.

Precautions

Colgate® Sensitive Pre-Procedural Desensitizing Paste should be used only by individuals professionally trained to perform dental prophylaxis. During use, wear protective glasses, mask and gloves.

Storage

Store at room temperature. Do not store pastes above 77°F (25°C). Keep out of direct sunlight. Close cap immediately after use to avoid moisture loss.

Lot Number and Expiration Date

The lot number should be quoted in all correspondences which requires identification of the product. Do not use after the expiration date. Rev. 6/13