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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03818945
Other study ID # Nourane Yasser
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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Completed NCT03285360 - Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity Phase 1
Completed NCT06358911 - A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability Phase 4
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Completed NCT01669785 - NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study N/A
Completed NCT04875000 - Hypersensitivity and Color Changes of Bleached Teeth Using Different Remineralizing Agents N/A