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.

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.

Study Overview

• Status: Recruiting
• Conditions: Fissure Sealant
• Intervention / Treatment: Other: Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Radwa Wael
    • Contact: radwa wael; Phone Number: 01274268817; Email: radwa.wael@dentistry.cu.edu.eg
    • Principal Investigator: Rania Mossalam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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
Active Comparator: 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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Anticipated): January 25, 2024
• Study Completion (Anticipated): June 25, 2024

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: giomer based fissure sealant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No