Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting

Caries; Initial Clinical Trial

Official title:

Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting Versus Total Etch Resin Based Sealant in High Caries Risk Patients After One Year Follow up

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04929327
• Other study ID #: CU-5-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: Rawda Hesham H Abd ElAziz, Post Phd
• Phone: 01001097200
• Email: rawda.hesham[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to clinically assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Patients who have existing pits and fissures that are anatomically deep and caries susceptible.

• Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

Exclusion Criteria:

• An individual with no previous caries experience and well coalesced pits and fissures.

• Partially erupted teeth.

• Teeth with cavitation or caries of the dentin.

• Teeth with dental fluorosis, Hypocalcification

Related Conditions & MeSH terms

• Caries; Initial
• Pit and Fissure Caries

Intervention

Procedure:
• Self etch Pit and fissure sealant application (prevent seal)
Sealing deep pits and fissures
• Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting
Sandblasting before Sealing deep pits and fissures
• Total etch resin based sealant ultraseal xt
Sealing deep pits and fissures

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	•Full retention (FR): the material was fully present on the occlusal surfaces •Partially lost (PL): the material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. •Totally lost (TL): no trace of the material was detected on the surface.	Change from baseline at 3, 6, 12 months