Clinical trial NCT04769882: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Microbial Colonization
Keywords: Er:YAG Laser
Oral Microbiota
Conservative Dentistry
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comparison of microbial load change after Er:YAG and conventional treatments
timeFrame: Measuring before any treatment and after treatments, through study completion, an average of 6 months
measure: Comparison of the effects of Er:YAG and conventional therapy in modifying the reduction of specific microbial species through mass spectrometry typing
timeFrame: Measuring before any treatment and after treatments, through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University Dental Clinic (C.O.U., Centro Odontostomatologico Universitario) of the University of Perugia
Study officials:
affiliation: Department of Medicine and Surgery
name: Stefano Cianetti
role: STUDY_DIRECTOR
References: