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Completed

NCT Number: NCT04769882

Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

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.

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Key information

Conditions

Dental Caries Communicable Diseases Disease Attributes Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Perugia, 06132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%)

Primary outcomes

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

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

    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 .

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

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

    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 .

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Official study title

Use of the Er:YAG Laser in Conservative Dentistry: Evaluation of the Microbial Population in Carious Lesions

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2021
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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