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

January 25, 2019 updated by: Nourane Yasser Ali, Cairo University

Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sodium Fluoride Varnish
Drug: Sodium fluoride varnish
5% sodium fluoride [22,600 ppm F-]
Other Names:
  • Biofluoride 5% Fluoride varnish single use dose - Vocoo
Active Comparator: PRG barrier Giomer
Drug: shofu PRG barrier coat
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)
Other Names:
  • Light cured giomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relieving of hypersensitivity
Time Frame: one month
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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nourane Yasser

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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