Total prosthetic replacement of the temporomandibular joint

4.1 A case series of 300 patients reported significant improvements in mean pain score (measured by visual analogue scale ranging from 0 to 5 with higher scores indicating more severe pain) from 1.18 at baseline to 0.03 at 1‑month follow‑up and 0 at 6‑month follow‑up (p<0.001 and p<0.0001 respectively). A case series of 288 patients reported significant improvements in mean pain scores (measured by visual analogue scale ranging from 0 to 10 with higher scores indicating worse pain) from 8.0 at baseline to 2.6 at 3‑year follow‑up (p<0.0001). A case series of 74 patients, using similar methods, reported a change from 7.2 at baseline to 0.8 at 1‑year follow‑up (p<0.0001).

4.2 The case series of 300 patients reported that mean diet score (measured by visual analogue scale ranging from 0 to 5 with lower scores representing a more restricted diet) improved from 2.16 at baseline to 4.96 at 1‑year follow‑up (n=300, p<0.0001). After 6 months, 80% (240/300) of patients reported a general diet with no limitations. At 5‑ and 7‑year follow‑up, the scores were 4.95 (n=166) and 4.93 (n=77) respectively. The case series of 288 patients reported improvements in mean diet score (measured by visual analogue scale ranging from 0 to 10 with 0 representing a normal diet and 10 representing liquids only) from 8.2 at baseline to 2.5 at 3‑year follow‑up (p<0.0001). The case series of 74 patients reported improvements in mean diet score (measured by visual analogue scale ranging from 0 to 10 with 0 representing liquids only and 10 representing a normal diet) from 3.8 at baseline to 9.3 at 1‑year follow‑up (p<0.0001).

4.3 A non‑randomised comparative study of 36 patients treated by total joint replacement or interpositional arthroplasty reported that the mean maximum inter‑incisal opening improved from 15.6 mm and 10.3 mm at baseline to 24.9 mm and 28 mm, respectively (p=0.02 between the groups for the change from baseline), after the procedure (median follow‑up of 12 months). The change in maximum inter‑incisal opening was not significantly different between the 2 groups after adjusting for institution, the number of previous operations, laterality, age and aetiology (p=0.056).The case series of 300 patients reported that the mean maximum inter‑incisal opening improved from 11.3 mm at baseline to 38.9 mm at 1‑year follow‑up (n=300, p<0.0001). The maximum inter‑incisal opening increased significantly at all follow‑up intervals during the 3‑year period after surgery, with no significant changes from the fourth year onwards. The 2 case series of 288 and 74 patients reported significant improvements in mean maximum inter‑incisal opening from 20.4 mm and 22.4 mm respectively at baseline to 29.5 mm (at 3‑year follow‑up) and 33.7 mm (at 1‑year follow‑up) respectively (p<0.0001).

4.4 The case series of 300 patients reported that mean function and speech scores (measured by visual analogue scale ranging from 0 to 5 where 0 represents no function and 5 represents optimal condition) improved significantly from 2.84 at baseline to 4.8 at 1‑year follow‑up (n=300, p<0.0001). At 5‑ and 7‑year follow‑up, the scores were 4.97 (n=166) and 4.92 (n=77) respectively. After 1 year, 85% of patients had an optimal score with regard to their speech and jaw movement capacity.

4.5 The case series of 288 patients reported that 46% of patients were enthusiastic about the procedure, 32% were very satisfied, 20% were satisfied and 2% were dissatisfied; 99.5% of patients reported that they would have the surgery again. The case series of 74 patients reported that 96% (71/74) of patients were very pleased with the procedure, 3% (2/74) were ambivalent and 1% (1/74) were dissatisfied.

4.6 The specialist advisers listed key efficacy outcomes as improvement in pain, improved eating ability scores and improvement in mouth opening.