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

NCT ID: NCT05336162

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2024-06-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Patients with non-cavitated pits and fissures in permanent molars will be treated with BeautiSealant

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).

Group Type: EXPERIMENTAL

Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)

Intervention Type: OTHER

A fissure sealant providing a physical barrier that inhibits microorganisms and food particles accumulation, preventing caries initiation, and arresting caries progression

Patients with non-cavitated pits and fissures in permanent molars will be treated with UltraSeal XT

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).

Group Type: ACTIVE_COMPARATOR

Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)

Intervention Type: OTHER

A fissure sealant providing a physical barrier that inhibits microorganisms and food particles accumulation, preventing caries initiation, and arresting caries progression

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Wael Maher

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Radwa Wael

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

radwa wael

Role: primary

radwa.wael@dentistry.cu.edu.eg

01274268817

Other Identifiers

giomer based fissure sealant

Identifier Type: -

Identifier Source: org_study_id