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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07493278

Enrollment

Registered

2026-03-25

Start date

2025-10-23

Completion date

2026-02-04

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Minimally invasive dentistry Er,Cr:YSGG laser Conventional mechanical excavation Streptococcus mutans Lactobacillus spp. Pediatric dentistry

Brief 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.

Interventions

PROCEDUREMechanical Caries Removal

Participants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments.

PROCEDUREEr,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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Laboratory personnel performing PCR analysis were blinded to the group assignments. Operators and participants were not blinded.

Intervention model description

Participants were randomly assigned to either conventional mechanical preparation (n=17) or Er,Cr:YSGG laser preparation (n=15). Laboratory personnel analyzing PCR results were blinded to group assignments.

Eligibility

Sex/Gender

ALL

Age

8 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Lesions located in the inner half of dentin, with a visible cavity or extensive dentin lesion (≥1 mm, measured with a periodontal graded probe) * Negative response to percussion * Absence of pulpal symptoms or spontaneous/night pain * Permanent molars or premolars fully erupted

Exclusion criteria

* Lesions involving less than half of the dentin or without a visible cavity * Teeth with significant crown destruction (ICDAS 06) * Positive response to percussion, pulpal symptoms, spontaneous/night pain * Teeth with periapical changes

Design outcomes

Primary

Measure	Time frame	Description
Change in levels of S. mutans and Lactobacillus spp. in dentin samples.	Before and immediately after caries removal	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.
Change in levels of S. mutans and Lactobacillus spp. in dentin samples	Before and immediately after caries removal	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.

Countries

Bulgaria

Contacts

STUDY_CHAIRNatalia Grancharova, MD, PhD

Medical University Sofia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026