Status:
COMPLETED
Ca-hydroxyapatite, Fluoroapatite, and Mg-Zn-hydroxyapatite for Dentin Hypersensitivity Management
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Dentin Hypersensitivity
Eligibility:
All Genders
35-45 years
Phase:
PHASE4
Brief Summary
This will be a double-blind, randomized, three-arm parallel groups study of the effect of toothpastes containing Ca-hydroxyapatite (HAP), Mg-Zn-hydroxyapatite (Zn-Mg-HAP), or fluoroapatite (FAP). The...
Detailed Description
Background: Dentin hypersensitivity (DH) represents a sharp, short pain arising from exposed dentin in response to various stimuli which cannot be ascribed to any other form of dental defect or pathol...
Eligibility Criteria
Inclusion
- aged between 35 and 45 years
- signed an approved Informed Consent Form, authorizing the participation in the trial and the use of the results of the trial for educational purposes and for the publication
- the diagnosis of dentin hypersensitivity stated clinically
- a premolar or first molar with an abrasive cervical defect of at least 1 millimeter, and not deeper than 1.5 millimeter, as measured by placing a periodontal probe into the deepest part of the cervical lesion; no mesial, distal or buccal restorations (to avoid confounding hypersensitivity)
- a hypersensitivity score of 2 or higher on the Shiff scale with standardized air-blast stimulation
- no other tooth in the same quadrant exhibiting hypersensitivity
Exclusion
- medical and pharmacotherapeutic histories that may compromise the protocol (pregnancy or breastfeeding, allergies to toothpastes ingredients, eating disorders)
- systemic conditions that are etiologic to dentin hypersensitivity (e.g., chronic acid regurgitation)
- excessive dietary or environmental exposure to acids
- periodontal surgery in the preceding 3 months
- orthodontic appliance treatment within previous 3 months
- teeth or supporting structures with any other painful pathology or defects
- teeth restored in the preceding 3 months
- abutment teeth for fixed or removable prostheses
- extensively restored teeth and those with restorations extending into the test area.
Key Trial Info
Start Date :
April 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04896294
Start Date
April 24 2021
End Date
July 19 2021
Last Update
October 1 2021
Active Locations (1)
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1
Institute of Dentistry of Sechenov University
Moscow, Russia, 121059