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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with non-cavitated pits and fissures in permanent molars will be treated with BeautiSealant | Experimental | Young adults (16-22 y) who have existing pits and fissures that are anatomically deep and caries susceptible or with Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). |
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| Patients with non-cavitated pits and fissures in permanent molars will be treated with UltraSeal XT | Active Comparator | Young adults (16-22 y) who have existing pits and fissures that are anatomically deep and caries susceptible or with Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA) | Other | A fissure sealant providing a physical barrier that inhibits microorganisms and food particles accumulation, preventing caries initiation, and arresting caries progression |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate of sealant | 1-Full retention: the materials were fully present on the occlusal surfaces. 2- Partially lost: the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. 3-Totally lost: no trace of materials was detected on the surface. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Caries Incidence | Intra-oral fluorescence camera VistaCamiX proof camera using (Software Program) | T0=Baseline immediate postoperative. T1= 3 months follow up. T2= 6 months follow up. T3=12 months follow |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radwa Wael | Recruiting | Cairo | Egypt |
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