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

Tooth Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03818945
• Other study ID #: Nourane Yasser
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Hypersensitivity

Intervention

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)
• Sodium fluoride varnish
5% sodium fluoride [22,600 ppm F-]

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one month