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

A

Alexandria University

Status

Enrolling

Conditions

Caries,Dental

Treatments

Procedure: Fluoride varnish application
Procedure: sub-ablative Er,Cr:YSGG laser

Study type

Interventional

Funder types

Other

Identifiers

NCT06826456
10556-0008839

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Participants of age 6-12 years old
  • Patients ranking definitely positive or positive on Frankl behavior rating scale
  • Having at least two bilateral fully erupted first permanent molars with untreated non-cavitated occlusal surfaces with deep grooves, the included teeth will have International Detection and Assessment System (ICDAS-II)/ severity scores 0, 1 or 2
  • Initial DIAGNOdent Score not exceeding value of 25 indicating only enamel involvement
  • Patients whom their parents are willing to comply with all study procedures and protocols and will be given an informed consent to participate

Exclusion criteria

  • Patients with any known medical history of systemic diseases
  • Patients having first permanent molar with hypoplastic or hypocalcified enamel
  • Patients using medications that may affect the oral flora or salivary flow
  • Patients treated with in-office fluoride treatment within the last 3 months prior to being enrolled in the study.
  • Patients showing evidence of poor oral hygiene according to Silness and Löe plaque index

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Laser irradiation
Experimental group
Description:
First permanent molars subjected to sub-ablative Er,Cr:YSGG laser
Treatment:
Procedure: sub-ablative Er,Cr:YSGG laser
Fluoride Varnish
Active Comparator group
Description:
First permanent molars subjected to fluoride varnish application
Treatment:
Procedure: Fluoride varnish application

Trial contacts and locations

1

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Central trial contact

Hussein Ezz Eldin

Data sourced from clinicaltrials.gov

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