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

NCT ID: NCT03818945

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-09-01

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.

Conditions

Tooth Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sodium Fluoride Varnish

Group Type: OTHER

Sodium fluoride varnish

Intervention Type: DRUG

5% sodium fluoride \[22,600 ppm F-\]

PRG barrier Giomer

Group Type: ACTIVE_COMPARATOR

shofu PRG barrier coat

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Sodium fluoride varnish

5% sodium fluoride \[22,600 ppm F-\]

Intervention Type: DRUG

Other Intervention Names

Light cured giomer; Biofluoride 5% Fluoride varnish single use dose - Vocoo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourane Yasser Ali

Principal investigator in Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Nourane Yassin, Bachelor

Role: primary

Nourane090248@miuegypt.edu.eg

01006889918

Aya Nemtallah, Master Degree

Role: backup

aya.mohammed@dentistry.cu.edu.eg

01006682419

Other Identifiers

Nourane Yasser

Identifier Type: -

Identifier Source: org_study_id