Clinical Trials Logo

Clinical Trial Summary

The chief aim of this study is to evaluate the difference in tooth sensitivity after having used a gel containing nano - hydroxyapatite and potassium nitrate

This randomized double-blind clinical study is designed to compare the efficacy in reducing dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium nitrate (Cavex Bite & White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste ( Colgate, Protection Caries, Palmolive SPA ).

Specific objectives :

To evaluate through standardized tests the dental sensitivity before and after the application of toothpastes; To compare the variations of dental sensitivity test and control groups.


determination of adverse reactions, such as increased tooth pain and changes in the oral mucosa after application of the materials.

Clinical Trial Description

Study Design

The study will be a clinical randomized double-blind trial monocentric.

The sample will be divided into three groups with 35 patients each one.


Patients enrolled in the study should not be submitted, for the whole duration of the trial, to local and systemic treatments for dentine hypersensitivity.


The randomization process shall be made using a table randomly generated by a computer. The researchers will not be involved in the randomization process.

Data Recording

The study involves the assessment of the following parameters:

During the first visit, data on the overall health and patient's mouth will be collected. All subjects, once included in the study, will receive scaling and polishing treatments.

All these patients will be visited the initial day, once again after 15 days, then after four weeks and eight weeks (end of follow-up). Each subject will be evaluated by the same dentist throughout the course of the trial. During each visit, only the hypersensitive teeth (selected in the beginning of the trial) will be evaluated, so that a minimum of two to a maximum of four sensitive teeth are stimulated by the means of tactile tests and with air spray test.

Tactile test: a sharp dental explorer (EXD 11-12, Hu-Friedy, Chicago, IL, USA) will be dragged on the vestibular side of each tooth, perpendicular to the long axis with a constant force. The test will be repeated three times before recording a score.

Tests air spray: a jet of air will be directed towards the affected tooth area for 1 second from a distance of 10 mm, using a standard air-water syringe, while the adjacent teeth will be isolated with cotton.

The tests with stimuli will be applied in the order previously indicated, with a break of 5 minutes between applications of different stimuli. For tests with stimuli, subjects' responses will be recorded using the following scale:

- 0 - No significant discomfort or awareness of the stimulus;

- 1 - Nuisance, but not acute pain;

- 2 - Acute pain during the application of the stimulus;

- 3 - Acute pain during and after the application of the stimulus.

At each time, a score will be given according to the sensation of pain felt by the patient using a numeric categorical scale with 0-10 parameters (VAS).

Withdrawal of Consent: The patient may at any time withdraw his consent to continue the study. Exit criteria are at the discretion of the researcher: patients who do not show the controls will be excluded from evaluation.

The following dental materials were used following the manufacturers' instructions:

1. Cavex Bite&White ExSense (Cavex Holland BV, RW Haarlem, The Netherlands), a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.

2. Colgate Protection Caries (Palmolive SPA), a fluoride-based gel toothpaste.

3. Placebo gel toothpaste (Baroniestraat, Amsterdam, The Netherlands), a glycerin and water gel. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

NCT number NCT02895321
Study type Interventional
Source Università degli Studi di Sassari
Status Completed
Phase Phase 4
Start date March 2016
Completion date September 2016

See also
  Status Clinical Trial Phase
Completed NCT02753075 - A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice. N/A
Completed NCT02861664 - Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity N/A
Completed NCT02542943 - Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity N/A
Completed NCT02226562 - Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity Phase 2
Completed NCT02919202 - Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity N/A
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
Completed NCT02923895 - To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) Phase 4
Not yet recruiting NCT03361774 - A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity Phase 2
Completed NCT02924350 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) N/A
Completed NCT02937623 - To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) N/A
Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
Completed NCT02293044 - A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity N/A
Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT02752958 - Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health N/A
Completed NCT02918617 - Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream Phase 2
Completed NCT01133379 - Tooth Sensitivity Relief by Two Mouthrinses N/A
Active, not recruiting NCT02770573 - Use of Biomaterials as Desensitizer Agents N/A
Completed NCT02832375 - Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity Phase 3
Completed NCT02406573 - A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity N/A