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RECRUITING
NCT06826456
NA

Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars

Sponsor: Alexandria University

View on ClinicalTrials.gov

Summary

Background: Subjecting human dental enamel to sub-ablative laser has been suggested as a novel way of caries prevention. However, further studies are needed to establish its use as a routine clinical procedure for caries prevention. The aim of this study: This study aims to evaluate the effect of Er,Cr:YSGG subablative laser irradiation on caries resistance of occlusal fissures of permanent molars. Materials and methods: In-vivo study, a split mouth randomized controlled trial with sixty patients having two fully erupted bilateral first permanent molars (ICDAS-II score 0,1 or 2). The pits and fissures will be subjected to sub-ablative power of Er,Cr:YSGG Laser (Group 1, n=90) and will be compared with fluoride varnish application on the first permanent molars in the same arch(Group 2,n=90). DIAGNOdentTM readings and changes in ICDAS-II score will be assessed at base line and at 3,6,9 and 12 months follow-up.

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-01-01

Completion Date

2025-08

Last Updated

2025-02-14

Healthy Volunteers

Yes

Conditions

Interventions

PROCEDURE

sub-ablative Er,Cr:YSGG laser

The irradiations will be done with an Er,Cr:YSGG laser device Er,Cr:YSGG Laser (Waterlase iPlus 2011,Biolase,Germany). This equipment emits photons at a wavelength of 2.78 µm. The repetition rate will be fixed at 20 Hz. The pulse duration will be fixed on 140 µs. The beam diameter at the focal area for the handpiece will be 600 µm. The tip will be positioned 1.0 mm from the enamel surface (focused mode). The handpiece will be positioned perpendicularly to the enamel. Power =0.25 Watt; energy density per pulse will be 62.5 J/cm2, Time = 20 seconds; Frequency = 20 Hz; without air/water. To ensure that each spot of a fissure was irradiated, each fissure will be irradiated for 2 min with overlapping irradiation

PROCEDURE

Fluoride varnish application

The first permanent molar assigned for control group will receive fluoride varnish applications. Fluoride varnish will be applied to all teeth in the oral cavity, including the laser-treated as well as the control tooth at baseline and the 6-month recall. Parents and children will be given age-appropriate oral hygiene instructions including proper teeth brushing with a 1100-ppm fluoride-containing dentifrice for at least 2 min twice daily especially before bedtime, as well as flossing if indicated.

Locations (1)

Alexandria University

Alexandria, Egypt