Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

NCT04769882 | Completed

• 1 other identifier: COU003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Microbial Colonization

Keywords

Er:YAG Laser; Oral Microbiota; Conservative Dentistry

Outcome Measures

Primary Outcomes (2)

• Comparison of microbial load change after Er:YAG and conventional treatments

  Swabbing of two samples from the cavity floor of lesions: before any treatment and after treatments (laser and traditional). Quantitative evaluation of the microbial population, in terms of Colony Forming Unit (CFU) by seeding the swabs taken in various types of media (Chocolate Agar, CNA Agar, Haemophilus Agar, Sabouraud, McConkey Agar, Shaedler Agar) and analysing the changes from baseline CFUs before any treatment and after Er:YAG laser and conventional therapies (control group and intervention group), comparing the effects of the two different types of treatment .

  Measuring before any treatment and after treatments, through study completion, an average of 6 months

• Comparison of the effects of Er:YAG and conventional therapy in modifying the reduction of specific microbial species through mass spectrometry typing

  Qualitative evaluation of the microbial species grown by mass spectrometry typing (MALDI TOF MS, Biomèrieux) of colonies freshly collected on culture plates, and analysis of the changes from baseline growth before any treatment and after Er:YAG laser and conventional therapies (control group and intervention group), comparing the effects on the growth of specific microbial populations of the two different types of treatment .

  Measuring before any treatment and after treatments, through study completion, an average of 6 months

Study Arms (2)

Er:YAG laser therapy group

ACTIVE COMPARATOR

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.

Device: Er:YAG Laser

Traditional therapy group

NO INTERVENTION

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.

Interventions

Er:YAG Laser 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%)

Er:YAG laser therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

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

Perugia, 06132, Italy

Location

MeSH Terms

Conditions

Dental Caries; Communicable Diseases

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Stefano Cianetti

  Department of Medicine and Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To ensure confidentiality of the data, each subject will be assigned a serial number so that only one of the experimenters will be able to link a number to the corresponding person. In addition, a dedicated computer will be used for data collection and analysis, which will be set up to allow limited access with a password known only to one of the experimenters.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Researcher

Model Details: The patients will be randomly assigned with a software (Excel 2007) to two groups: group A, control group, which includes treatment with traditional therapy; group B, intervention group, which includes treatment with Er:YAG laser therapy.

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 25, 2021
• Study Start: September 7, 2020
• Primary Completion: October 5, 2020
• Study Completion: December 18, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

IT (1)