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the Efficacy of Giomer Versus Sodium Fluoride in the Treatment of Hypersensitivity

Primary Purpose

Tooth Hypersensitivity

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
shofu PRG barrier coat
Sodium fluoride varnish
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Hypersensitivity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged from 18 to 40 years.
  • No gender restriction.
  • Patients should have pain score in the visual analog scale two or more.
  • Patients must have at least one sensitive tooth in one of four quadrants.

Exclusion Criteria:

  • Patients with active carious lesions.
  • Needing restorative treatment.
  • Receiving periodontal treatment.
  • Taking desensitizing treatment in the last 6 months.
  • Taking anti-inflammatory drugs.
  • Pregnant patients.
  • Smokers.

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Sodium Fluoride Varnish

PRG barrier Giomer

Arm Description

Outcomes

Primary Outcome Measures

relieving of hypersensitivity
The sensitive teeth will be assessed by two stimuli: tactile and thermal stimuli than scored according to the visual analog scale from zero to ten.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2019
Last Updated
January 25, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03818945
Brief Title
the Efficacy of Giomer Versus Sodium Fluoride in the Treatment of Hypersensitivity
Official Title
Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
to solve the problem of hypersensitivity, I will use two different materials ( Giomer versus Sodium Fluoride) and compare between their effects in reliving the symptoms
Detailed Description
The dentin hypersensitivity is characterized by short, sharp pain which can be detected by several methods. The problem is very annoying for the patients and making them seek for effective rapid treatment. It can affect several teeth in one area of the mouth or only one specific tooth. Careful diagnosis of such condition necessitates precise differentiation of its signs and symptoms from the other causes of tooth sensitivity which may be resulted from dental caries, micro leakage, cracked tooth or fractured restoration. There are two well-known ways to reduce the discomfort of the hypersensitivity either by blocking the exposed dentinal tubules by occluding materials or use some depolarizing agents that reducing the excitability of the intra dental nerves.Most of the desensitizing agents reduces the dentin hypersensitivity by its own way and each one has different long lasting effect. But there are some drawbacks that appeared with their use. Fluoride based agents were appeared in 90's but it was clarified that their high concentration irritated the odontoblasts. Furthermore, the oxalates and potassium nitrate were introduced to treat the hypersensitivity effectively but their effects did not persist for a long period of time. Sodium fluoride varnish is one from the most commonly used desensitizing agent and its efficacy was approved in many studies. The Giomer varnish containing surface pre-reactive glass particles (S-PRG) is a light-cured protective varnish and it was introduced to promote prolonged protection for the hypersensitive dentin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium Fluoride Varnish
Arm Type
Other
Arm Title
PRG barrier Giomer
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
shofu PRG barrier coat
Other Intervention Name(s)
Light cured giomer
Intervention Description
Trilaminar structure which forms a type of stable glass ionomer allowing ion release and recharge, while protecting the glass core from the damaging effects of moisture, greatly improving long-term durability.(Na, BO3, Al, SiO3, F,Sr)
Intervention Type
Drug
Intervention Name(s)
Sodium fluoride varnish
Other Intervention Name(s)
Biofluoride 5% Fluoride varnish single use dose - Vocoo
Intervention Description
5% sodium fluoride [22,600 ppm F-]
Primary Outcome Measure Information:
Title
relieving of hypersensitivity
Description
The sensitive teeth will be assessed by two stimuli: tactile and thermal stimuli than scored according to the visual analog scale from zero to ten.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged from 18 to 40 years. No gender restriction. Patients should have pain score in the visual analog scale two or more. Patients must have at least one sensitive tooth in one of four quadrants. Exclusion Criteria: Patients with active carious lesions. Needing restorative treatment. Receiving periodontal treatment. Taking desensitizing treatment in the last 6 months. Taking anti-inflammatory drugs. Pregnant patients. Smokers.
Facility Information:
Facility Name
Faculty of Dentistry
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nourane Yassin, Bachelor
Phone
01006889918
Email
Nourane090248@miuegypt.edu.eg
First Name & Middle Initial & Last Name & Degree
Aya Nemtallah, Master Degree
Phone
01006682419
Email
aya.mohammed@dentistry.cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

the Efficacy of Giomer Versus Sodium Fluoride in the Treatment of Hypersensitivity

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