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

Investigation of the Incidence of Caries in Pits and Fissures Sealed With Bioactive Sealant

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03628729
Enrollment
80
Registered
2018-08-14
Start date
2018-08-31
Completion date
2019-01-31
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pit and Fissure Caries

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.

Interventions

OTHEREmbrace™ 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

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

Fluoride releasing resin based pits and fissures sealant

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
caries incidencesix monthsdevelopment of pit and fissure caries

Contacts

Primary Contactmohamed heiba
m.tarek.heiba@gmail.com01000568165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026