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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pit and Fissure Caries; Caries; Initial
• Intervention / Treatment: Procedure: Self etch Pit and fissure sealant application (prevent seal); Procedure: Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting; Procedure: Total etch resin based sealant ultraseal xt

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rawda Hesham H Abd ElAziz, Post Phd; Phone Number: 01001097200; Email: rawda.hesham@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11331
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-etch resin based sealant; Self-etch resin based sealant (prevent seal) without prior sandblasting.	Procedure: Self etch Pit and fissure sealant application (prevent seal); Sealing deep pits and fissures
Active Comparator: Prior Sandblasting; Self-etch resin based sealant prevent seal) with prior sandblasting.	Procedure: Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting; Sandblasting before Sealing deep pits and fissures
Active Comparator: Total-etch resin based sealant; Total-etch resin based sealant (ultraseal XT) (Ultradent Pro. Inc., USA)	Procedure: Total etch resin based sealant ultraseal xt; Sealing deep pits and fissures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Rawda Hesham H. Abd ElAziz, Post Phd, Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pit and fissure sealant; Sandblasting; Air abrasion; Retention rate
• Other Study ID Numbers: CU-5-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No