Nano-hydroxyapatite With Potassium Nitrate in the Therapy of the Dental Sensitivity

NCT02895321 | Completed Phase 4 DMC

• 1 other identifier: DH 2362CE
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

nano-hydroxyapatite; potassium nitrate

Outcome Measures

Primary Outcomes (1)

• Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment

  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.

  baseline, 4 weeks, and 8 weeks

Study Arms (1)

Patients with dentin hypersensitivity

EXPERIMENTAL

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; Other: Colgate, Protection Caries; Other: Placebo gel

Interventions

Cavex Bite&White ExSense OTHER

a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.

Patients with dentin hypersensitivity

Colgate, Protection Caries OTHER

a fluorine-based toothpaste gels

Patients with dentin hypersensitivity

Placebo gel OTHER

a glycerin and water gel

Patients with dentin hypersensitivity

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Complex Operative Unit of Dentistry

Sassari, Sassari, 07100, Italy

Location

Related Publications (4)

• Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.

  PMID: 22891890 BACKGROUND

• Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.

  PMID: 25609032 BACKGROUND

• Vano M, Derchi G, Barone A, Genovesi A, Covani U. Tooth bleaching with hydrogen peroxide and nano-hydroxyapatite: a 9-month follow-up randomized clinical trial. Int J Dent Hyg. 2015 Nov;13(4):301-7. doi: 10.1111/idh.12123. Epub 2015 Jan 20.

  PMID: 25600272 BACKGROUND

• Vano M, Derchi G, Barone A, Covani U. Effectiveness of nano-hydroxyapatite toothpaste in reducing dentin hypersensitivity: a double-blind randomized controlled trial. Quintessence Int. 2014 Sep;45(8):703-11. doi: 10.3290/j.qi.a32240.

  PMID: 25019114 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Egle Milia, Prof

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: September 9, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)