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

NCT05336162 | Unknown

• 1 other identifier: giomer based fissure sealant
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fissure Sealant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Caries Incidence

  T0=Baseline immediate postoperative. T1= 3 months follow up. T2= 6 months follow up. T3=12 months follow

Study Arms (2)

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).

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

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).

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

Interventions

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

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

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Radwa Wael

Cairo, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 20, 2022
• Study Start: January 25, 2023
• Primary Completion: January 25, 2024
• Study Completion: June 25, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

EG (1)