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

Not Applicable

Recruiting

• Conditions: Caries,Dental

• Registration Number: NCT06826456
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnodent scoring	day 0, 3 months, 6 months, 12 months	evaluate the dental caries activity of fissures by comparing changes in DIAGNOdent readings. Laser induced fluorescence (DIAGNOdentTM) will be used to quantitatively determine lesion demineralization which is displayed as numerical values ranging from 0 to 99. A decrease in the signal indicates regression of the carious lesion, whereas an increase indicates progression. The DIAGNOdent tip will be then placed on the measurement site, and slightly tilted circular movements will be performed along the entire fissure pattern. The patient will be included in the study if the DIAGNOdent readings of both bilateral first permanent molar do not exceed 25.

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt