Data sources: The Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Library Issue 2 from 2003, Medline and Embase were all data sources. Relevant journals were also searched by hand and the reference lists of chosen studies were screened. Experts in the field were contacted and there were no language restrictions. Study selection: To be selected, the studies had to be randomised controlled trials (RCT) or quasi-RCT, in which splint therapy was compared concurrently with no treatment, other occlusal appliances or any other active intervention. Data Extraction and synthesis: Data extraction was carried out independently and in duplicate. Validity assessment of the chosen trials was carried out at the same time as data extraction. Discrepancies were discussed and a third reviewer consulted. The author of the primary study was contacted where necessary. The studies were grouped according to treatment type and duration of follow-up. Results: Twenty potentially relevant RCT were identified. Eight were later excluded, leaving 12 trials for analysis. Stabilisation splint therapy (SS) was compared with: acupuncture, bite plates, biofeedback/stress management, visual feedback, relaxation, jaw exercises, non-occluding appliance and minimal/no treatment. There was no evidence of a statistically significant difference in the effectiveness of SS in reducing symptoms in patients with pain dysfunction syndrome (PDS) compared with other active treatments. There was weak evidence to suggest that the use of SS for the treatment of PDS may be beneficial for reducing pain severity, at rest and on palpation, compared with no treatment. Conslusions: There is insufficient evidence either for or against the use of SS for the treatment of temporomandibular PDS. This review suggests the need for further, rigorous RCT that consider the method of allocation and outcome assessment, have large sample size and sufficient duration of follow-up. A standardisation of the outcomes of the treatment of PDS should be established in the RCT.