This is a proposal requesting three more years of funding for a clinical trial comparing rigid and wire fixation. The objective of this ongoing randomized clinical trial is to compare the efficacy and cost-effectiveness of these two most commonly used surgical stabilization procedures when used in the most common orthognathic procedure - mandibular advancement. Secondary objectives are to identify patient risk factors and describe the complications associated with these two procedures. These objectives are being accomplished through a multisite randomized clinical trial involving patients who were randomized to receive wire or rigid fixation. By the end of existing funding period, these patients will complete a 2-year follow-up. The present proposal is for completion of a 5-year follow-up for a set of 98 patients from 2 of the 3 centers involved in the current study. Assessment of the 2-year data showed trends in surgical, functional and psychosocial outcomes. The addition of follow-up to 5 years is anticipated to clarify these trends. The trial will have 80 percent power to detect clinically meaningful differences between the groups on all primary outcomes. Treatment differences relate to measures of stability of the surgical outcome, neurosensory function, masticatory performance, quality of life, patient satisfaction and cost effectiveness.

National Institute of Health (NIH)
National Institute of Dental & Craniofacial Research (NIDCR)
Research Project (R01)
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Special Emphasis Panel (ZDE1-GH (38))
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University of Texas Health Science Center San Antonio
Schools of Dentistry
San Antonio
United States
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Frey, Daniela Rezende; Hatch, John P; Van Sickels, Joseph E et al. (2008) Effects of surgical mandibular advancement and rotation on signs and symptoms of temporomandibular disorder: a 2-year follow-up study. Am J Orthod Dentofacial Orthop 133:490.e1-8
Frey, Daniela Rezende; Hatch, John P; Van Sickels, Joseph E et al. (2007) Alteration of the mandibular plane during sagittal split advancement: short- and long-term stability. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 104:160-9
Chuang, S-K; Hatch, J P; Rugh, J et al. (2005) Multi-center randomized clinical trials in oral and maxillofacial surgery: modeling of fixed and random effects. Int J Oral Maxillofac Surg 34:341-4
Cain, Karin K; Rugh, John D; Hatch, John P et al. (2002) Readiness for orthognathic surgery: a survey of practitioner opinion. Int J Adult Orthodon Orthognath Surg 17:7-11
Dolce, Calogero; Hatch, John P; Van Sickels, Joseph E et al. (2002) Rigid versus wire fixation for mandibular advancement: skeletal and dental changes after 5 years. Am J Orthod Dentofacial Orthop 121:610-9
Van Sickels, Joseph E; Hatch, John P; Dolce, Calogero et al. (2002) Effects of age, amount of advancement, and genioplasty on neurosensory disturbance after a bilateral sagittal split osteotomy. J Oral Maxillofac Surg 60:1012-7
Hatch, John P; Rugh, John D; Sakai, Shiro et al. (2002) Reliability of the craniomandibular index. J Orofac Pain 16:284-95
Hatch, J P; Van Sickels, J E; Rugh, J D et al. (2001) Mandibular range of motion after bilateral sagittal split ramus osteotomy with wire osteosynthesis or rigid fixation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 91:274-80
Chung, D H; Hatch, J P; Dolce, C et al. (2001) Positional change of the hyoid bone after bilateral sagittal split osteotomy with rigid and wire fixation. Am J Orthod Dentofacial Orthop 119:382-9
Shinkai, R S; Hatch, J P; Sakai, S et al. (2001) Masticatory performance is not associated with diet quality in Class II orthognathic surgery patients. Int J Adult Orthodon Orthognath Surg 16:214-20

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