Nano-hydroxyapatite With Potassium Nitrate in the Therapy of the Dental Sensitivity
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|ClinicalTrials.gov Identifier: NCT02895321|
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : October 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Dentin Sensitivity||Other: Cavex Bite&White ExSense Other: Colgate, Protection Caries Other: Placebo gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial to Evaluate the Efficacy of Nano-hydroxyapatite Combined With the Potassium Nitrate for the Treatment of Dental Sensitivity|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Patients with dentin hypersensitivity
Patients with evident clinical signs of dentin hypersensitivity. The following dental materials will be used following the manufacturers' instructions: Cavex Bite&White ExSense and Colgate Protection Caries and Placebo gel.
In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.
The effectiveness will be evaluated: immediately after application and after 2, 4, 8 weeks.
Other: Cavex Bite&White ExSense
a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
Other: Colgate, Protection Caries
a fluorine-based toothpaste gels
Other: Placebo gel
a glycerin and water gel
- Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment [ Time Frame: baseline, 4 weeks, and 8 weeks ]The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895321
|Complex Operative Unit of Dentistry|
|Sassari, Italy, 07100|
|Principal Investigator:||Egle Milia, Prof||Università degli Studi di Sassari|