An interventional study of Mechanical Caries Removal and Er,Cr:YSGG Laser Caries Removal in Dental Caries, sponsored by Medical University of Sofia. Completed at 1 site in Bulgaria. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Medical University of Sofia · Not applicable, Interventional, and Treatment
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.
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
Participants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments.
Procedure: Mechanical 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.
Procedure: Er,Cr:YSGG Laser Caries Removal
Participants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments.
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
Change in levels of S. mutans and Lactobacillus spp. in dentin samples.
The presence of S. mutans and Lactobacillus spp. in dentin samples will be assessed using PCR. Samples are collected before and after mechanical or Er,Cr:YSGG laser caries removal to determine bacterial reduction for both microorganisms.
Time frame: Before and immediately after caries removal
Change in levels of S. mutans and Lactobacillus spp. in dentin samples
The presence of S. mutans and Lactobacillus spp. in dentin samples will be assessed using PCR. Samples are collected before and after mechanical or Er,Cr:YSGG laser caries removal to determine bacterial reduction for both microorganisms.
Time frame: Before and immediately after caries removal
Plan to share: No — Individual participant data will not be shared in order to protect patient privacy and comply with ethical approvals and consent restrictions.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Medical University of Sofia