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The aim of this study is assessing the effectiveness of the Er:YAG laser in relation to the use of conventional surgery in the treatment of drug-induced osteonecrosis of the jaws (MRONJ). The study compares two main treatments for advanced cases of MRONJ or cases that do not show improvement despite conservative or non-surgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with the Er:YAG laser | Experimental |
| |
| Patients treated with the conventional surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irradiation with Er:YAG laser | Procedure | An Er:YAG laser (LightTouch, LightInstruments, Yokneam, Israel) was used with the following parameters: 400mJ (millijoules), 6W (Watt), 15Hz (Hertz), 5/8 water cooling, laser tip with a diameter of 800 microns. Tissue debridement continued until hard, healthy, lively bleeding bone was exposed, indicative of normal bone. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Occurrence or absence of complications | Up to 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Severity of Osteonecrosis | Incidence of grade II/III necrosis or no severe necrosis | 3 and 6 months after treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kinga Grzech-Leśniak, DDS, MS PhD | Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland and Department of Periodontics, School of Dentistry Virginia Commonwealth University, 12th St, Richmond, VA 23298, USA | Study Director |
| Marzena Dominiak, Prof. dr hab n. med. | Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical University | Wroclaw | Poland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 |
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|
| Tissue preparation | Procedure | Rose-shaped rotary drills (8 mm diameter) were used with water cooling at a speed not exceeding 40.000 rpm. Tissue preparation limits were consistent with those used for the Er:YAG laser group. |
|
| Jun 10, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2021 | Jun 10, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011827 | Radiation |
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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