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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Cianetti | Department of Medicine and Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Dental Clinic (C.O.U., Centro Odontostomatologico Universitario) of the University of Perugia | Perugia | 06132 | Italy |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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.
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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.
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |