Study protocol for a randomized controlled clinical trial
Natalia Osorio Viarengo, MS, Marcela Leticia Leal Gonçalves, PhD, [...], and Sandra Kalil Bussadori, PhD
Reference
(Ref ID): PMC9646657
Chosen Image filename: PMC9646657_Figure_02.jpg
Document structure and format:
I. Introduction
This research paper, titled "Evaluation of intravascular irradiation of blood in children with sleep bruxism: Study protocol for a randomized controlled clinical trial," investigates the effects of intravascular irradiation of blood (ILIB) combined with myofunctional exercises for sleep bruxism in children. Sleep bruxism is a repetitive activity involving clenching or grinding of teeth during sleep or wakefulness and can lead to various negative consequences if not addressed. The objective of this study is to evaluate the efficacy of ILIB in combination with myofunctional therapy in treating sleep bruxism in pediatric patients.
II. Methodology
The study adopts a randomized controlled clinical trial design. The participants, aged between 4 and 17 years old, with a diagnosis of sleep bruxism, are recruited from the Catholic University of Uruguay clinic and private care centers. A total of 46 patients will be divided into two groups: a control group receiving placebo ILIB and orofacial myofunctional therapy (MFT), and an ILIB group receiving active ILIB and MFT. Data will be collected through questionnaires on bruxism, sleep quality, and nocturnal oxygen saturation measurement. Statistical tests, such as the Kolmogorov-Smirnov test and t-tests, will be conducted to analyze the data. It is important to note that the research may have limitations and underlying assumptions inherent to the study design and data collection methods.
III. Results
The key findings of the study are as follows:
The efficacy of ILIB combined with myofunctional exercises for sleep bruxism in pediatrics is being evaluated for the first time.
Bruxism has a multifactorial etiology, including genetic causes, occlusal factors, malocclusion, and respiratory problems.
Polysomnography is considered the definitive diagnostic method for bruxism but is costly.
Therapeutic approaches for bruxism are mostly palliative, with limited evidence for drug interventions.
Photobiomodulation (PBM), specifically ILIB, and orofacial myofunctional therapy (MFT) are potential alternative therapies.
The study aims to determine the efficacy of ILIB in combination with MFT and explore the relationship between oxygenation and bruxism during sleep.
IV. Discussion
In the discussion, the researchers analyze and interpret the results in relation to the research question and objectives. They highlight the potential implications and significance of the study's findings, such as providing a non-invasive and low-cost treatment option for sleep bruxism in children. The researchers also acknowledge any limitations of the study and suggest areas for further research. They emphasize the importance of early identification and treatment of bruxism to prevent negative consequences and improve the overall well-being of children.
V. Conclusion
In conclusion, this research paper evaluates the use of intravascular irradiation of blood (ILIB) in combination with orofacial myofunctional therapy (MFT) for treating sleep bruxism in pediatric patients. The study contributes to the understanding of potential non-invasive and low-cost treatment options for bruxism. Early identification and intervention are crucial in preventing long-term consequences and improving the quality of life for children affected by bruxism. Further research is needed to explore the efficacy and long-term effects of ILIB and MFT in larger populations.
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