Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05336162 |
Other study ID # |
giomer based fissure sealant |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 25, 2023 |
Est. completion date |
June 25, 2024 |
Study information
Verified date |
March 2023 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
With limited evidence-based information in literature about using giomer based pit and
fissure sealant(BeautiSealant) in non-cavitated pits and fissures in permanent molars, it is
beneficial to evaluate the newly introduced material using a randomized controlled clinical
trial to test the null hypothesis that this new pit and fissure sealant (BeautiSealant,
Shoufu, USA). will have the same effect as resin based pit and fissure sealant (UltraSeal XTâ„¢
plus, Ultradent, USA) regarding retention rate and caries preventive effect.
Description:
Giomer is an adhesive material in dentistry made from resin that contains a Pre-Reacted
Glass- ionomer (PRG) filler. The advantages of Giomer include the release and recharge of
fluoride, resistance to acid, anti-plaque effect, remineralization of dentin, and acid
buffering capacity. The surface pre-reacted glass-ionomer filler containing sealant
(BeautiSealant) demonstrated superior fluoride recharging properties. BeautiSealant is filled
with Shofu's proprietary S-PRG (Surface Pre-Reacted Glass) with cariostatic properties, acid
neutralization, and plaque inhibition decreasing the risk for secondary caries. Beautisealant
unlike traditional sealants which require phosphoric acid etching, demineralizing and
dehydrating healthy teeth, shoufu's self etching primer is significantly less acidic helping
to preserve healthy tooth structure and still maintaining equal or better shear bond
strength. The clinical use of self-etching agents could be recommended before pit and fissure
sealants application in new dental protocols. No clinical trials have been published uptill
now evaluating caries incidence around giomer based fissure sealant by VistaCam iX proof. The
aim of this study is to Evaluate the retention rate of self etch giomer based fissure sealant
and also caries incidence using VistaCamiX.