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

Phase 4

• Conditions: Tooth Hypersensitivity
• Interventions: Drug: Sodium fluoride varnish; Drug: shofu PRG barrier coat

• Registration Number: NCT03818945
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Study First Posted: 2019-01-28
• Last Update Posted: 2019-01-28
• Study Start: 2019-03-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Fluoride Varnish	Sodium fluoride varnish	-
PRG barrier Giomer	shofu PRG barrier coat	-

Primary Outcome Measures

Name	Time	Method
relieving of hypersensitivity	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.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Giza, Egypt