Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial
Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP
Trials · 31 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Universidade Nove de Julho
- Gobierno
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Gobierno
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Subvenciones
- Fundação de Amparo à Pesquisa do Estado de São Paulo (13/23404-0); Conselho Nacional de Desenvolvimento Científico e Tecnológico (303662/2012-3)
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2013-11-06 · Trials · vol. 14 · número 1 · pág. 373
- Editorial
- Springer Science+Business Media
- Citado
- 54 citas · más que el 79% de estudios similares · 1.2× el promedio de su campo
- Referencias
- 34 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Laser Applications in Dentistry and Medicine · Biofield Effects and Biophysics · Medical and Biological Ozone Research
- Palabras clave
- low-level laser therapy, impacted third molar extraction, postoperative pain, postoperative swelling, masticatory muscle spasm, oral health-related quality of life, 660 nm laser, 808 nm laser, postoperative inflammation
- MeSH
- masticatory muscles, molar, third, humans, spasm, facial pain, inflammation, pain measurement, treatment outcome, clinical protocols, tooth extraction, double-blind method, research design, time factors, quality of life, brazil, surveys and questionnaires, low-level light therapy
6 autores
- Simone Oliveira Sierra🇧🇷Universidade Nove de Julho
- Alessandro Melo Deana🇧🇷Universidade Nove de Julho
- Raquel Agnelli Mesquita‐Ferrari🇧🇷Universidade Nove de Julho
- Priscilla Maia Albarello🇧🇷Universidade Nove de Julho
- Sandra Kalil Bussadori🇧🇷Universidade Nove de Julho
- Kristianne Porta Santos Fernandes🇧🇷 · autor de correspondenciaUniversidade Nove de Julho
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Low-level laser therapy (LLLT) has been shown to modulate the inflammatory process without adverse effects , by reducing pain and swelling and promoting the repair of damaged tissues. Because pain, swelling and muscle spasm are complications found in virtually all patients following oral surgery for the removal of impacted teeth, this model has been widely used to evaluate the effects of LLLT on the inflammatory process involving bone and, connective tissue and the muscles involved in mastication.
Methods/design
After meeting the eligibility criteria, 60 patients treated at a Specialty Dental Center for the removal of impacted lower third molars will be randomly divided into five groups according to the type of laser therapy used at the end of surgery (intraoral irradiation with 660 nm laser; extraoral irradiation with 660 nm laser; intraoral irradiation with 808 nm laser; extraoral irradiation with 808 nm laser and no irradiation). To ensure that patients are blinded to the type of treatment they are receiving, the hand piece of the laser apparatus will be applied both intraorally and extraorally to all participants, but the device will be turned on only at the appropriate time, as determined by the randomization process. At 2 and 7 days after surgery, the patients will be evaluated by three blinded evaluators who will measure of swelling, mouth opening (muscle spasm evaluation) and pain (using two different pain scales). The 14-item Oral Health Impact Profile (OHIP-14) will be used to assess QOL. All data will be analyzed with respect to the normality of distribution using the Shapiro-Wilk test. Statistically significant differences between the experimental groups will be determined using analysis of variance, followed by a suitable post hoc test, when necessary. The significance level will be set at α = 0.05.
Discussion
The lack of standardization in studies with regard to the samples, methods and LLLT parameters complicates the determination of the actual effect of laser therapy on this model. The present study aims to provide a randomized, controlled, double-blind trial to compare four different LLLT parameters in relation to the outcomes of pain, swelling and muscle spasm following surgery for the extraction of impacted third molars and evaluate the effects os surgery on patients' quality os life (QOL).
Trial registration
Brazilian Registry of Clinical Trials - Rebec (RBR-6XSB5H).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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