ClinicalTrials.Veeva

Menu

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

M

Medical University of Sofia

Status

Completed

Conditions

Dental Caries

Treatments

Procedure: Er,Cr:YSGG Laser Caries Removal
Procedure: Mechanical Caries Removal

Study type

Interventional

Funder types

Other

Identifiers

NCT07493278
14/28.09.2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

8 to 15 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

Mechanical Preparation
Experimental group
Description:
Participants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments.
Treatment:
Procedure: Mechanical Caries Removal
Er,Cr:YSGG Laser Preparation
Experimental group
Description:
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.
Treatment:
Procedure: Er,Cr:YSGG Laser Caries Removal

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems