NCT05336162

Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant

Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant Versus Total Etch Resin Based Fissure Sealant in Patients With Non- Cavitated Pits and Fissures in Permanent Molars Over One Year.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 16 Years – 22 Years
• Healthy volunteers: Accepted

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 XT™ plus, Ultradent, USA) regarding retention rate and caries preventive effect.

Detailed 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.

Conditions

• Fissure Sealant

Interventions

Type	Name	Description
OTHER	Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)	A fissure sealant providing a physical barrier that inhibits microorganisms and food particles accumulation, preventing caries initiation, and arresting caries progression

Timeline

• Start date: 2023-01-25
• Primary completion: 2024-01-25
• Completion: 2024-06-25
• First posted: 2022-04-20
• Last updated: 2023-03-29

Locations

1 site across 1 country: Egypt