Er:YAG Laser Effects on Microbial Population in Conservative Dentistry

Not Applicable

Completed

• Conditions: Dental Caries; Microbial Colonization

• Registration Number: NCT04769882
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2020-09-07
• Primary Completion: 2020-10-05
• Study Completion: 2020-12-18
• Status Verified: 2021-02
• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of microbial load change after Er:YAG and conventional treatments	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 .
Comparison of the effects of Er:YAG and conventional therapy in modifying the reduction of specific microbial species through mass spectrometry typing	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 .

Trial Locations

Locations (1)

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