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

NCT07493278 | Completed

• 1 other identifier: 14/28.09.2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Before and immediately after caries removal

Study Arms (2)

Mechanical Preparation

EXPERIMENTAL

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

Er,Cr:YSGG Laser Preparation

EXPERIMENTAL

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

Interventions

Er,Cr:YSGG Laser Caries Removal PROCEDURE

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

Er,Cr:YSGG Laser Preparation

Mechanical Caries Removal PROCEDURE

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

Mechanical Preparation

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Sofia: lead
• European Union Next Generation: collaborator

Study Sites (1)

Medical University of Sofia, Faculty of Dental Medicine

Sofia, Sofia, 1431, Bulgaria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Natalia Grancharova, MD, PhD

  Medical University Sofia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory personnel performing PCR analysis were blinded to the group assignments. Operators and participants were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: October 23, 2025
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)