Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

NCT ID: NCT04769882

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2020-12-18

Brief Summary

The aim of this study is to verify the quantitative and qualitative effect of Erbium dental laser therapy on microbial populations in carious lesions and to compare the laser therapy with traditional conservative therapies.

Detailed Description

Patients will be assessed and selected at the University Odontostomatology Clinic (COU) in Perugia; patients are considered eligible for enrolment if they are at least 18 years old and have a carious lesion on permanent teeth, cavitated and non-destructive, deepening to the middle third of the dentine and no further. The patients will be randomly assigned to two groups as follows: group A, control group, which includes treatment with traditional therapy; group B, intervention group, which includes treatment with Er:YAG laser therapy. For each patient, two salivary swabs will be taken on the cavity dentine of the carious lesion: one before and one after the treatments.

Conditions

Dental Caries; Microbial Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Er:YAG laser therapy group

The removal of caries was performed with Er:YAG laser (Doctor Smile, Lambda SRL,Italy) with BOOST handpiece to cut the enamel and open the cavity, and 90° handpiece to remove the carious dentin with tips of 800 µ in diameter and 8 mm or 12 mm in length, in relation to the depth and distance of the lesion.

Group Type: ACTIVE_COMPARATOR

Er:YAG Laser

Intervention Type: DEVICE

Selected Er:YAG settings: "enamel removal" program for adult, with "normal" modality (frequency: 20 Hz, energy: 400 mJ, power: 8.0 W, air: 80%, water: 60%) and "dentin removal" program for adult, with "normal" modality (frequency: 20 Hz, energy: 200 mJ, power: 4.0 W, air: 90%, water: 30%)

Traditional therapy group

The removal of caries was performed with manual and rotating instruments, such as dentin spoon (ASA Dental S.p.a.), turbine (NSK Dental Italy S.r.l.) with diamond burs (Kerr Dental Italia S.r.l.) to cut the enamel and open the cavity and drill handpiece (KaVo Dental Italia S.r.l.) with tungsten carbide burs (Kerr Dental Italia S.r.l.) to remove the infected dentin.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Er:YAG Laser

Selected Er:YAG settings: "enamel removal" program for adult, with "normal" modality (frequency: 20 Hz, energy: 400 mJ, power: 8.0 W, air: 80%, water: 60%) and "dentin removal" program for adult, with "normal" modality (frequency: 20 Hz, energy: 200 mJ, power: 4.0 W, air: 90%, water: 30%)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients of both sexes with at least 18 years of age and one cavitated non-destructive carious occlusal lesion of a permanent teeth, that deepens up to the middle third of the dentin and not beyond, confirmed by radiographic exam and without pulp involvement.

Exclusion Criteria

• patients that refused to sign the informed consent document;
• children or individuals with less than 18 years;
• pregnant subjects;
• patients with syndromes or chronic systemic diseases;
• patients who had used antibiotics within the previous three months or under pharmacological treatments;
• patients with painful symptoms consistent with irreversible pulpitis or mobility and destructive carious lesions extending beyond the middle third of the dentin;
• teeth with exposure of the dental pulp or periodontitis;
• patients with caries on deciduous teeth;
• patients with no cooperation during the radiographical exam and/or treatments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Guido Lombardo

University Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Cianetti

Role: STUDY_DIRECTOR

Department of Medicine and Surgery

Locations

University Dental Clinic (C.O.U., Centro Odontostomatologico Universitario) of the University of Perugia

Perugia, , Italy

Countries

Italy

Other Identifiers

COU003

Identifier Type: -

Identifier Source: org_study_id