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

Cairo University (CU)

Status: Unknown

Conditions: Pit and Fissure Caries

Treatments: Other: Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA; Other: Embrace™ WetBond™ Pit & Fissure Sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT03628729

CEBD-CU-2018-07-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Embrace™ WetBond™ Pit & Fissure Sealant.

Experimental group

Description:

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

Treatment:

Other: Embrace™ WetBond™ Pit & Fissure Sealant

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

Active Comparator group

Description:

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

Treatment:

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