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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 25, 2024
Est. primary completion date January 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 22 Years
Eligibility Inclusion Criteria: - Young adults (16-22 y). - Patients who have existing pits and fissures that are anatomically deep and caries susceptible. - Permanent molars teeth without any caries and cavitation. - Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures. •Permanent molar teeth with stained grooves. - Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). Exclusion Criteria: - Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure. - Patients allergic to sealant material. - Patient with history of medical disease, drug therapies or any other serious relevant problem. - An individual with no previous caries experience and well coalesced pits and fissures - Partially erupted teeth. - Teeth with cavitation or caries of the dentin. - A large restoration is present on occlusal Surface. - If pits and fissures are self-cleansable. - Teeth with dental fluorosis, hypocalcification or hyper calcification.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Radwa Wael Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT04854720 - Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars N/A
Completed NCT02063815 - A Trial of Caries Prevention Effect of Fissure Sealants N/A
Completed NCT03718689 - Effect of Er:YAG Laser on Hydrophilic Sealants N/A
Active, not recruiting NCT03235960 - Efficacy of Glass-ionomer Fissure Sealants N/A