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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
Sponsor:
Information provided by (Responsible Party):
Egle Milia, Università degli Studi di Sassari

Brief 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.

Safety:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be considered suitable for the study if they had sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine.

Exclusion Criteria:

  • Teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study.
  • Professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
  • Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).

Information from the National Library of Medicine

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


Locations
Italy
Complex Operative Unit of Dentistry
Sassari, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
Investigators
Principal Investigator: Egle Milia, Prof Università degli Studi di Sassari

Publications:
Responsible Party: Egle Milia, Prof, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT02895321     History of Changes
Other Study ID Numbers: DH 2362CE
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not a plan for data sharing has been established. But, for anyone researcher would like to have this information, simply they may request them to us directly.

Keywords provided by Egle Milia, Università degli Studi di Sassari:
nano-hydroxyapatite
potassium nitrate

Additional relevant MeSH terms:
Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents