Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent-A prospective clinical study.

Purpose: The aim of this study was to investigate the feasibility of a custom made alloplastic Temporomandibular Joint (TMJ) device design in patients undergoing temporomandibular (TM) Total Joint Reconstruction (TJR).

Objective: TMJ disease with functional and anatomic distortion dictates the need for TJR. There are various materials to reconstruct a TMJ. However, various factors, such as cost, availability of prosthetic joint, limit its use to tertiary health care center. Hence, we have investigated the feasibility and efficacy of the custom made alloplastic TMJ prosthesis (DARSN TM Joint Prosthesis) with the advantage of being acceptable financially and the overall Quality of life (QoL) diagnosed with TMJ ankylosis and End Stage Joint Disease (ESJD) selected from the study population.

Materials And Methods: The study group comprised of 20 patients with TMJ ankylosis or End Stage Joint Disease (ESJD) who needed TM TJR of which few subjects in the study population had history of failed previous surgery to the TMJ region. The patients underwent resection of the joint followed by TJR using the custom made alloplastic TMJ prosthesis. Various subjective and objective variables were evaluated such as the Jaw Function (JF), Inter-incisal opening (IO), Diet intake (DI), Quality of Life (QoL) using a Psychometric Modified Likert Scale and nutritional status of the patient using the Mid-Upper Arm Circumference (MUAC) as reference.

Results: All the subjective and objective variables showed significant improvement in the postoperative period as compared to the preoperative period. The JF score increased with a mean score of 6.25 (P<0.00001). Postoperative mean DI score was 3.15 (P<0.00001) and IO increased up to 29-38mm in 95% of the study population. The study population exhibited an improved overall QoL and nutritional status post-operatively. Follow up period of 1 year showed significant functional improvement among the study population.

Conclusion: The results shows that the custom made alloplastic joint replacement is safe and effective and reliable alternative to treat patients with TMJ disease which restricts the normal function to a greater degree requiring TM TJR.