Abstract
The purpose of this study was to investigate in vivo the biomechanical and morphological changes in soft palates of Wistar rats from non-ablative irradiation with a 9.3-μm CO2 laser. A blinded, randomized, controlled study was designed with 45 Wistar rats categorized into treated and control sets. The treated set was exposed to 9.3-μm CO2 laser irradiation at an average power of 1.0 W and a single pulse fluence of 0.16 J/cm2 scanned using an automated system at a repetition rate of 315 Hz in a patterned area covering 0.4 cm2 in 6 s. The tissue of each animal was excised and divided into two halves. One-half was sectioned for histopathology, and the other half was used to measure tissue stiffness, which was reported as the effective Young’s modulus. Measurements for both sets were taken at three time points: days 1, 21, and 35. There were no significant adverse events or changes in the behavior of the rats over the duration of the study. The treated set exhibited an order of magnitude increase in stiffness relative to the controls, which was maintained over the three time points. Histopathology showed a moderate contraction/disruption of the lamina propria collagen observed at day 1 and collagen accumulation observed at days 21 and 35 in the tissue remodeling phase. Non-ablative 9.3-μm CO2 laser irradiation can safely increase oral mucosal stiffness and can be used as an effective treatment to reduce tissue vibrations that are associated with snoring.
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Acknowledgments
Dr. Xin Brown of Boston University provided access to the device used in the biomechanics portion of this study and helped to train the authors on the use of nanoindentation. She also provided some idea of the initial indentation parameters that might work for this method on soft tissues. Dr. Gregory Rybacki of Toxikon, Inc., provided the histopathology analysis of the oral mucosa.
Funding
This study was funded by Convergent Dental.
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This study did not unnecessarily duplicate previous testing and that there were no non-animal alternatives acceptable for the evaluation of the test article as defined by the protocol. No evidence of pain and distress was reported to the Veterinarian or Study Director. Toxikon strictly adhered to the following standards in maintaining the animal care and use program:
United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service, 9 CFR Ch. 1, Subchapter A-Animal Welfare.
“Guide for the Care and Use of Laboratory Animals,” National Research Council, 2011.
Office for Laboratory Animal Welfare (OLAW), “Public Health Service Policy on Humane Care and Use of Laboratory Animals,” Health Research Extension Act of 1985 (Public Law 99–158 November 20, 1985), Revised 2015.
ISO 109932, 2006, Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements.
AAALAC International accreditation.
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Badreddine, A.H., Couitt, S. & Kerbage, C. Histopathological and biomechanical changes in soft palate in response to non-ablative 9.3-μm CO2 laser irradiation: an in vivo study. Lasers Med Sci 36, 413–420 (2021). https://doi.org/10.1007/s10103-020-03087-y
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DOI: https://doi.org/10.1007/s10103-020-03087-y