NCT07493278

Er,Cr:YSGG Laser Versus Conventional Preparation for Minimally Invasive Caries Removal

Er,Cr:YSGG Laser Versus Conventional Preparation for Minimally Invasive Caries Removal: Clinical PCR Study of Streptococcus Mutans and Lactobacillus Spp. in Dentin Reference to the Main Project (Sub-study of Strategic Research and Innovation Program for Development of Medical University - Sofia, BG-RRP-2.004-0004-C01)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medical University of Sofia · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This study compared two standard methods for minimally invasive caries removal in children: conventional mechanical excavation and Er,Cr:YSGG laser preparation. The study aimed to evaluate the reduction of Streptococcus mutans and Lactobacillus spp. in dentin using PCR analysis. All procedures were performed as part of routine dental care, and written informed consent was obtained from parents or legal guardians.

Detailed description

This comparative clinical study included 32 carious lesions in permanent molars and premolars from children aged 8-15 years. Lesions were randomly assigned to either conventional mechanical preparation (n=17) or Er,Cr:YSGG laser preparation (n=15). Samples of carious and affected dentin were collected before and after preparation, and bacterial DNA was analyzed using PCR for S. mutans and Lactobacillus spp. The study followed ethical approval from the Ethics Committee of the Medical University of Sofia (protocol № 14/28.09.2023), and written informed consent was obtained from all parents/guardians. The study was conducted entirely within the framework of routine dental treatment, with standard, clinically approved methods applied for all participants. Statistical analysis included descriptive statistics, Wilcoxon signed-rank test for within-group comparisons, and Mann-Whitney U test for between-group comparisons.

Conditions

• Dental Caries

Interventions

Type	Name	Description
PROCEDURE	Mechanical Caries Removal	Participants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments.
PROCEDURE	Er,Cr:YSGG Laser Caries Removal	Participants received caries removal using the Er,Cr:YSGG laser (2780 nm) according to manufacturer-recommended parameters for minimally invasive dentin excavation. Laboratory personnel analyzing PCR results were blinded to group assignments

Timeline

• Start date: 2025-10-23
• Primary completion: 2026-02-04
• Completion: 2026-02-04
• First posted: 2026-03-25
• Last updated: 2026-03-30

Locations

1 site across 1 country: Bulgaria