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Trial record 6 of 292 for:    Sodium Fluoride OR Duraphat

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03818945
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Information provided by (Responsible Party):
Nourane Yasser Ali, Cairo University

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

Condition or disease Intervention/treatment Phase
Tooth Hypersensitivity Drug: shofu PRG barrier coat Drug: Sodium fluoride varnish Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Sodium Fluoride Varnish Drug: Sodium fluoride varnish
5% sodium fluoride [22,600 ppm F-]
Other Name: 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 Name: Light cured giomer

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT03818945

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Faculty of Dentistry Recruiting
Giza, Egypt
Contact: Nourane Yassin, Bachelor    01006889918   
Contact: Aya Nemtallah, Master Degree    01006682419   
Sponsors and Collaborators
Cairo University

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Responsible Party: Nourane Yasser Ali, Principal investigator in Cairo university, Cairo University Identifier: NCT03818945     History of Changes
Other Study ID Numbers: Nourane Yasser
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sodium Fluoride
Fluorides, Topical
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents