Dental CariesNCT07493278
Er,Cr:YSGG Laser Versus Conventional Preparation for Minimally Invasive Caries Removal
A study testing Mechanical Caries Removal and Er,Cr:YSGG Laser Caries Removal in people with Dental Caries, run by Medical University of Sofia at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Mechanical Caries Removal and Er,Cr:YSGG Laser Caries Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBulgaria
- Study dates
- 23 Oct 2025to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical University of Sofia, Faculty of Dental Medicine
Sofia, Sofia, 1431
About this study
Official title: 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)
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.
Read the 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
- Being tested
- Mechanical Caries Removal, Er,Cr:YSGG Laser Caries Removal
- Keywords
- Minimally invasive dentistry Er,Cr:YSGG laser Conventional mechanical excavation Streptococcus mutans Lactobacillus spp. Pediatric dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Caries RemovalProcedure or surgery
Participants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments.
Er,Cr:YSGG Laser Caries RemovalProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Er,Cr:YSGG Laser Caries Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and immediately after caries removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start23 Oct 2025
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Natalia Grancharova, MD, PhD, Study chair, Medical University Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493278
- Sponsor's protocol ID
- 14/28.09.2023
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect patient privacy and comply with ethical approvals and consent restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07493278
- Acronym / sponsor ID
- 14/28.09.2023
- Conditions
- Dental Caries
- Keywords
- Minimally invasive dentistry Er,Cr:YSGG laser Conventional mechanical excavation Streptococcus mutans Lactobacillus spp. Pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Preparation | Experimental | Procedure: Mechanical Caries RemovalParticipants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments. |
| Er,Cr:YSGG Laser Preparation | Experimental | Procedure: Er,Cr:YSGG Laser Caries RemovalParticipants 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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Caries RemovalParticipants received conventional mechanical caries removal according to standard pediatric dentistry protocols. Laboratory personnel analyzing PCR results were blinded to group assignments. | Procedure or surgery | Mechanical Preparation |
| Er,Cr:YSGG Laser Caries RemovalParticipants 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 or surgery | Er,Cr:YSGG Laser Preparation |
Primary outcome
Change in levels of S. mutans and Lactobacillus spp. in dentin samples.
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect patient privacy and comply with ethical approvals and consent restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Grancharova, MD, PhD study chair
Medical University Sofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Caries Removal and Er,Cr:YSGG Laser Caries Removal in people with Dental Caries, run by Medical University of Sofia at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of S. mutans and Lactobacillus spp. in dentin samples. (time frame: Before and immediately after caries removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.