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

Pit and Fissure Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03628729
• Other study ID #: CEBD-CU-2018-07-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: January 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: mohamed heiba
• Phone: 01000568165
• Email: m.tarek.heiba[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Pit and Fissure Caries

Intervention

Other:
• 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
• Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA
Fluoride releasing resin based pits and fissures sealant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries incidence	development of pit and fissure caries	six months