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

Trials

Kristianne Porta Santos Fernandes¹  Sandra Kalil Bussadori¹  Priscilla Maia Albarello²  Raquel Agnelli Mesquita Ferrari¹  Alessandro Melo Deana¹  Simone Oliveira Sierra² 

[1] Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho (UNINOVE), Rua Vergueiro, 235, São Paulo, SP CEP: 01504-001, Brazil;Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), Rua Vergueiro, 235, São Paulo, SP CEP: 01504-001, Brazil

关键词: Randomized controlled trial;    Tooth extraction;    Repair;    Inflammation;    Laser;   

Others  :  807939
DOI  :  10.1186/1745-6215-14-373

 received in 2013-04-04, accepted in 2013-10-21,  发布年份 2013

【 摘 要 】

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).

【 授权许可】

   
2013 Oliveira Sierra et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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