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

NCT03628729 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-07-17
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pit and Fissure Caries

Outcome Measures

Primary Outcomes (1)

• caries incidence

  development of pit and fissure caries

  six months

Study Arms (2)

Embrace™ WetBond™ Pit & Fissure Sealant.

EXPERIMENTAL

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

Other: Embrace™ WetBond™ Pit & Fissure Sealant

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

ACTIVE COMPARATOR

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

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

Interventions

Embrace™ WetBond™ Pit & Fissure Sealant 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

Embrace™ WetBond™ Pit & Fissure Sealant.

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

Fluoride releasing resin based pits and fissures sealant

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

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Pit and Fissure Sealants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

mohamed heiba

CONTACT

01000568165; m.tarek.heiba@gmail.com

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 14, 2018
• Study Start: August 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 16, 2018

Record last verified: 2018-08