How Far Are Vacuum Therapy and Stabilization Splints Efficacious for the Management of Temporo-mandibular Joint Osteoarthritis? A Randomized Clinical Trial.

Study design and patients´ selection:

This prospective parallel randomized clinical trial included patients diagnosed with TMJ osteoarthritis. All Patients were collected from the TMD clinic of Prosthodontics Department, Faculty of Dentistry, Mansoura University. The study was approved by the local ethics committee with ethical approval number A12060922. All patients were aware of the treatment procedures and signed informed consents for their participation. Patients were recruited and data collection was performed between . CONSORT guidelines were followed when approperiate19 Inclusion and exclusion criteria were defined prior to the beginning of the study. Inclusion criteria were: (I) clinical diagnosis of TMJ osteoatrhritis according to diagnostic criteria involved in the DC/TMD axis I group 3.A.2 item20 including self-report of TMJ pain, tenderness to palpation, and crepitus (II) magnetic resonance imaging (MRI)signs of joint effusion, erosions and ⁄ or sclerosis of the cortical outline, flattening of the joint surfaces and ⁄ or osteophyte formation ; and (III) age cognitively capable of understanding the standardized questionnaire.

Exclusion criteria were: (I) Patients with systemic disease affecting the joints (II) previous TMJ treatment, (III) previous trauma to TMJ or to the jaws, and (IV) edentulous patients, (V) use of anti-inflammatory drugs at least one month before assessment and during the treatment period.

Sample size calculation:

Sample size calculation was performed by using G*Power software (version 3.1.9.7) based on previous study by El-Shaheed et al.21 A medium effect size (f = 0.25) for interaction effect of treatment group and time on quantitative outcomes (amount of mouth opening in mm, temporo-mandibular joint palpation and VAS score for pain) and a large effect size (f = 0.4) for main group effect on these outcome measures were hypothesised. Based on these assumptions, a total sample size of 42 (14 in each treatment group) achieved 83% power to detect a large effect size (f = 0.4) with 0.05 α-error probability using F test anova: Repeated measures, between factors for three groups and five measurements with a .5 correlation between measurements.