Investigation of the Incidence of Caries in Pits and Fissures Sealed With Bioactive Sealant Compared to Fluoride Releasing Resin Based Pit and Fissure Sealant

NCT ID: NCT03628729

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2019-01-31

Brief Summary

This study will be conducted to investigate the incidence of caries in pits and fissures sealed with a bioactive sealant compared to a fluoride releasing resin based pits and fissures sealant in preventive treatment procedures in adult population over a six months period.

Detailed Description

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Tarek Heiba. The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 40 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be randomly divided into two groups according to type of sealant (S) where in group S1, pits and fissures will be sealed with bioactive pits-and-fissure sealant; while group S2, pits and fissures will be sealed with fluoride releasing resin based pits and fissures sealant. Each restoration will be assessed after three, six months,The tooth will be illuminated with a violet light approximately 405 nm thus stimulating both prophyrins to emit red light that contains less energy. the denser the bacteria colonization on tooth's surface, the more intense the red fluorescent signal; in contrast sound enamel sent out a green fluorescent signal. These light signals are recorded by the highly developed optics and analyzed by the device's software. The software filters and quantifies the fluorescence emitted by the dental tissue and converts the relationship between green and red.

Conditions

Pit and Fissure Caries

Study Design

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

Study Groups

Embrace™ WetBond™ Pit & Fissure Sealant.

pits and fissures will be sealed with bioactive pits-and-fissure sealant

Group Type: EXPERIMENTAL

Embrace™ WetBond™ Pit & Fissure Sealant

Intervention Type: OTHER

pit and fissure sealant that contain the precursor in the formation of hydroxyapatite which is Amorphous Calcium Phosphate (ACP) ,which has anti-cariogenic effect as well as remineralization potential as it contain bioactive material which stimulate crystal growth within the lesion by increasing the concentration of calcium and phosphate ions

Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA

Pits and fissures will be sealed by fluoride releasing resin based pits and fissures sealant

Group Type: ACTIVE_COMPARATOR

Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA

Intervention Type: OTHER

Fluoride releasing resin based pits and fissures sealant

Interventions

Embrace™ WetBond™ Pit & Fissure Sealant

pit and fissure sealant that contain the precursor in the formation of hydroxyapatite which is Amorphous Calcium Phosphate (ACP) ,which has anti-cariogenic effect as well as remineralization potential as it contain bioactive material which stimulate crystal growth within the lesion by increasing the concentration of calcium and phosphate ions

Intervention Type: OTHER

Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA

Fluoride releasing resin based pits and fissures sealant

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients should be 16-25 Years old
• Patient should have good oral hygiene and general health with at least 2 •sound intact occlusal surfaces of first and/or second molar teeth in each quadrant of maxilla or mandible.

Exclusion Criteria

• Known allergy to any of the resins used
• Clinically detectable caries
• Previously placed sealants or restorations
• Bruxism or malocclusion

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed tarek heiba

Master student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mohamed heiba

Role: CONTACT

m.tarek.heiba@gmail.com

01000568165

Other Identifiers

CEBD-CU-2018-07-17

Identifier Type: -

Identifier Source: org_study_id