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Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

Primary Purpose

Dental Caries, Microbial Colonization

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Er:YAG Laser
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Er:YAG Laser, Oral Microbiota, Conservative Dentistry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Er:YAG laser therapy group

Traditional therapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 .
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 .

Secondary Outcome Measures

Full Information

First Posted
February 14, 2021
Last Updated
February 21, 2021
Sponsor
University Of Perugia
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1. Study Identification

Unique Protocol Identification Number
NCT04769882
Brief Title
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
Official Title
Use of the Er:YAG Laser in Conservative Dentistry: Evaluation of the Microbial Population in Carious Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Microbial Colonization
Keywords
Er:YAG Laser, Oral Microbiota, Conservative Dentistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Er:YAG laser therapy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional therapy group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Er:YAG Laser
Intervention Description
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%)
Primary Outcome Measure Information:
Title
Comparison of microbial load change after Er:YAG and conventional treatments
Description
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 .
Time Frame
Measuring before any treatment and after treatments, through study completion, an average of 6 months
Title
Comparison of the effects of Er:YAG and conventional therapy in modifying the reduction of specific microbial species through mass spectrometry typing
Description
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 .
Time Frame
Measuring before any treatment and after treatments, through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Cianetti
Organizational Affiliation
Department of Medicine and Surgery
Official's Role
Study Director
Facility Information:
Facility Name
University Dental Clinic (C.O.U., Centro Odontostomatologico Universitario) of the University of Perugia
City
Perugia
ZIP/Postal Code
06132
Country
Italy

12. IPD Sharing Statement

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Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

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