NCT06765330

Brief Summary

The aim of this study was to investigate the effects of cavity disinfection with laser and chlorhexidine on the microbiome in cavities prepared using different caries removal methods.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 3, 2025

Last Update Submit

January 3, 2025

Conditions

Dental Caries

Keywords

dental cariesdisinfectionlaserchlorhexidine gluconatepyrosequencing

Outcome Measures

Primary Outcomes (1)

  • Microbiome Changes

    In all groups, dentin samples will be taken from the affected dentin at the base of the cavity as a result of three different subgroup disinfection procedures applied after the caries removal method using 2 sterile number 6 round sterile steel roun burs moistened with saline for microbial analysis. The burs will be placed in 5 ml sterile vials and stored at -80 0C until the analyses are performed. The prepared cavities will be completed with routine and standard treatment protocols. Following the finishing and polishing procedures, occlusion will be checked. The samples collected during the research process will be delivered to the A\&D Genetic Diseases Evaluation Centre (Ankara, Turkey) where DNA isolation and sequence analysis will be performed together with molecular biologists. In the method, following the extraction of total genomic DNA from clinical samples, broad-range 16S rRNA PCR will be performed and MicroSeq 500 16S rRNA Sequencing kit will be used for sequence analysis.

    3 months

Study Arms (6)

Group 1: Non-selective caries removal with tungsten carbide bur + No cavity disinfection

ACTIVE COMPARATOR

Access to the lesion will be achieved using a high-speed handpiece with a sterile high-speed bur (#245 bur Meisinger GmbH, Germany). The caries removal strategy towards soft dentin will be performed following the guidelines published by the International Caries Consensus Collaboration. The caries will be completely removed from the surrounding cavity walls with a tungsten carbide bur, leaving at least 2 mm of peripheral intact tooth structure for good adaptation and sealing of the restoration. Superficial necrotic caries fragments, which deform when an instrument is pressed into them and can be easily removed with little force, will be removed from the pulpal floor using a sharp sterile excavator, while soft dentin will be left at the cavity floor to avoid pulpal exposure. Following caries removal, the tooth will be restored without any cavity disinfection.

Procedure: Tungsten carbide bur

Group 2: Non-selective caries removal with tungsten carbide bur + 2% chlorhexidine disinfection

ACTIVE COMPARATOR

Following the caries removal protocol applied in Group 1, 2% chlorhexidine (Consepsis®, Ultradent) will be applied to the cavity for 20 seconds. The cavity will then be air-dried for 10 seconds, and the tooth will be restored.

Drug: CHX disinfectionProcedure: Tungsten carbide bur

Group 3: Non-selective caries removal with tungsten carbide bur + Er,Cr: YSGG laser disinfection

ACTIVE COMPARATOR

Following the caries removal protocol applied in Group 1, the cavity will be disinfected using an Er,Cr: YSGG laser (EPIC X™, BIOLASE, USA) with 940 nm and 0.1 W output power. Then, the tooth will be restored.

Device: Laser DisinfectionProcedure: Tungsten carbide bur

Group 4: Selective caries removal with polymer bur + No cavity disinfection

ACTIVE COMPARATOR

Access to the lesion will be achieved using a high-speed handpiece with a sterile high-speed bur (#245 bur Meisinger GmbH, Germany). The SS White Smartburs II® will be used with a low-speed handpiece at 5,000-10,000 RPM to remove carious dentin of sizes RA4, RA6, and RA8 depending on the size of the caries lesion. The instrument will be used with a circular, light force starting from the center of the carious lesion towards the periphery as recommended by the manufacturer. Caries removal will be stopped when the instrument is macroscopically worn and blunt and can no longer remove tissue. An explorator will be used to verify if any caries remain at the base of the cavity. If necessary, a new polymer bur, SmartbursII®, will be used to remove the remaining decay. After selective caries removal, the tooth will be restored without any cavity disinfection.

Procedure: Polymer bur

Group 5: Selective caries removal with polymer bur + 2% chlorhexidine disinfection

ACTIVE COMPARATOR

Following the selective caries removal protocol applied in Group 4, 2% chlorhexidine (Consepsis®, Ultradent) will be applied to the cavity for 20 seconds. The cavity will then be air-dried for 10 seconds, and the tooth will be restored.

Drug: CHX disinfectionProcedure: Polymer bur

Group 6: Selective caries removal with polymer bur + Er,Cr: YSGG laser disinfection

ACTIVE COMPARATOR

Following the selective caries removal protocol applied in Group 4, the cavity will be disinfected using an Er, Cr: YSGG laser (EPIC X™, BIOLASE, USA) with 940 nm and 0.1 W output power. Then, the tooth will be restored.

Device: Laser DisinfectionProcedure: Polymer bur

Interventions

CHX disinfectionDRUG

Each CHX cavity will be treated with disinfectant with a disposable micro brush tip and left undisturbed for 20 seconds. They will then be air-dried for 10 seconds and restore the tooth.

Group 2: Non-selective caries removal with tungsten carbide bur + 2% chlorhexidine disinfectionGroup 5: Selective caries removal with polymer bur + 2% chlorhexidine disinfection
Laser DisinfectionDEVICE

After the caries removal procedure, the cavity will be disinfected using an Er,Cr: YSGG laser (EPIC X™, BIOLASE, USA) with 940 nm and 0.1 W output power. The laser tip will be a 400 µm tip with an energy density of 138.12 J/cm in non-contact mode (2 mm distance), 5 s/mm2 sweeping motion.

Group 3: Non-selective caries removal with tungsten carbide bur + Er,Cr: YSGG laser disinfectionGroup 6: Selective caries removal with polymer bur + Er,Cr: YSGG laser disinfection
Tungsten carbide burPROCEDURE

Carious tissue will be completely removed from the surrounding cavity walls with a tungsten carbide bur, leaving at least 2 mm of peripheral intact tooth structure for good adaptation and sealing of the restoration.

Group 1: Non-selective caries removal with tungsten carbide bur + No cavity disinfectionGroup 2: Non-selective caries removal with tungsten carbide bur + 2% chlorhexidine disinfectionGroup 3: Non-selective caries removal with tungsten carbide bur + Er,Cr: YSGG laser disinfection
Polymer burPROCEDURE

Access to the lesion will be achieved using a high-speed handpiece with a sterile high-speed bur. The polymer bur will be used with a low-speed handpiece at 5,000-10,000 RPM to remove carious dentin in sizes RA4, RA6, and RA8 according to the size of the caries lesion. The instrument will be used with a circular, light force starting from the center of the carious lesion towards the periphery as recommended by the manufacturer. Caries removal will be stopped when the instrument is macroscopically worn and blunt and can no longer remove tissue. An excavator will be used to verify if any caries remain at the base of the cavity. If necessary, a new polymer bur will be used to remove the remaining decay.

Group 4: Selective caries removal with polymer bur + No cavity disinfectionGroup 5: Selective caries removal with polymer bur + 2% chlorhexidine disinfectionGroup 6: Selective caries removal with polymer bur + Er,Cr: YSGG laser disinfection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Permanent molar/premolar teeth in which the carious lesion is on the occlusal surface and extends to the middle third of the dentin at most
  • Individuals with good oral hygiene
  • Absence of clinical symptoms of periapical pathology
  • Teeth in occlusion with the opposite tooth
  • Individuals born in 2007 and before (\>18 years)
  • Those who signed the Informed Voluntary Consent Form/Written Consent Form

You may not qualify if:

  • Irregular attendance at dental check-ups
  • Severe systemic disease, allergy, and saliva flow disorder
  • Poor oral hygiene
  • Advanced periodontal disease
  • Presence of clinically detected pulpal/periapical pathology
  • Devitalisation of teeth
  • The individual was born after 2007 (\<18 years)
  • Those who do not sign the Informed Voluntary Consent Form/Written Consent Form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University, Faculty of Dentistry, Department of Restorative Dentistry

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Ayse Tugba Erturk Avunduk, Associate Profesor

    Mersin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozcan Karatas, Associate Profesor

CONTACT

+90 554 268 2981ozcnkrts@gmail.com

Ebru Delikan, Associate Profesor

CONTACT

+ 90 506 381 74 54e.delikan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The randomization of the participants for this study will be carried out on the previously determined date and time using the address https://randomizer.org/
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Group 1: Non-selective caries removal with tungsten carbide bur + No cavity disinfection Group 2: Non-selective caries removal with tungsten carbide bur + 2% chlorhexidine disinfection Group 3: Non-selective caries removal with tungsten carbide bur + Er, Cr: YSGG laser disinfection Group 4: Selective caries removal with polymer bur + No cavity disinfection Group 5: Selective caries removal with polymer bur + 2% chlorhexidine disinfection Group 6: Selective caries removal with polymer bur + Er, Cr: YSGG laser disinfection
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 9, 2025

Study Start

May 5, 2025

Primary Completion

August 29, 2025

Study Completion

September 15, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)