Functional Appliance for Orthognathic Surgery

NCT05009056 | Completed DMC

• 1 other identifier: Orthognathic surgery
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The unstable condylar position in the glenoid fossa is a critical problem for postsurgical instability after mandibular advancement with subsequent mandibular relapse. The habitual forward occlusion in class II patients creates unstable condyle to glenoid fossa relationship making it hard for clinicians to determine the amount of mandibular advancement. Splint therapy is considered as a preoperative reversible nonsurgical condylar repositioning option in addition to its adjunctive effect for pain relief in TMJ symptomatic patients. To minimize this relapse, presurgical functional appliance therapy has been proposed and has shown promising outcomes.

Conditions

Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

• Change from postoperative sagital position of the mandible at 12 months (skeletal stability)

  Method of Measurement: Lateral cephalogram Unit of Measurement: mm

  immediately postoperative and 12 months later

Secondary Outcomes (1)

• Assessment of condylar deviation

  immediately postoperative and 12 months later

Other Outcomes (2)

• Distal segment linear deviation

  immediately postoperative and 12 months later

• Distal segment angular deviations

  immediately postoperative and 12 months later

Study Arms (2)

postsurgical computer guided functional appliance

EXPERIMENTAL

After achieving ideal condylar poison by computer guided surgery. The distal extension of the final occlusal wafer will be cut and the appliance will be fitted to be utilized as a postsurgical functional appliance for condylar adaptation. Patients will be instructed to wear the splints continuously for 3 months, only being allowed to remove them when eating and brushing their teeth.

Device: Postsurgical computer guided functional appliance

Presurgical computer guided functional appliance

ACTIVE COMPARATOR

Using the software, 3D digitized mandible will be virtually repositioned in ideal centric relation through accurate adjustment of the condyle in its glenoid fossa. Patients' dental casts will be scanned, and digitized into a virtual 3D model and superimposed to the CT cuts into the virtual plan software environment in order to produce preoperative CAD/CAM splint on the adjusted centric occlusion. Patients will be instructed to wear the splints continuously for 3 months, only being allowed to remove them when eating and brushing their teeth.

Device: Postsurgical computer guided functional appliance

Interventions

Postsurgical computer guided functional appliance DEVICE

After achieving ideal condylar poison by computer guided surgery. The distal extension of the final occlusal wafer will be cut and the appliance will be fitted to be utilized as a postsurgical functional appliance for condylar adaptation. Patients will be instructed to wear the splints continuously for 3 months, only being allowed to remove them when eating and brushing their teeth.

Presurgical computer guided functional appliance; postsurgical computer guided functional appliance

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age of the patient above 18 years
• Patients in need of bilateral sagittal split osteotomy for mandibular advancement.
• All patients are free from any systemic disease that may affect normal bone healing.
• Sufficient dentition to reproduce the occlusal relationships
• Patient's consent to participate

You may not qualify if:

• Patients with any systemic disease that may affect normal healing
• Intra-bony lesions or infections that may interfere with surgery
• Previous orthognathic surgeries

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

outpatient clinic of Oral and Maxillofacial Surgery department- Cairo University

Cairo, 11553, Egypt

Location

Related Publications (12)

• Ha N, Hong Y, Qu L, Chung M, Qu R, Cai X, Fang B, Jiang L. Evaluation of post-surgical stability in skeletal class II patients with idiopathic condylar resorption treated with functional splint therapy. J Craniomaxillofac Surg. 2020 Mar;48(3):203-210. doi: 10.1016/j.jcms.2020.01.004. Epub 2020 Jan 11.

  PMID: 32008874 BACKGROUND

• Bailey L', Cevidanes LH, Proffit WR. Stability and predictability of orthognathic surgery. Am J Orthod Dentofacial Orthop. 2004 Sep;126(3):273-7. doi: 10.1016/S0889540604005207. No abstract available.

  PMID: 15356484 BACKGROUND

• Proffit WR, Turvey TA, Phillips C. The hierarchy of stability and predictability in orthognathic surgery with rigid fixation: an update and extension. Head Face Med. 2007 Apr 30;3:21. doi: 10.1186/1746-160X-3-21.

  PMID: 17470277 BACKGROUND

• Costa F, Robiony M, Toro C, Sembronio S, Polini F, Politi M. Condylar positioning devices for orthognathic surgery: a literature review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Aug;106(2):179-90. doi: 10.1016/j.tripleo.2007.11.027. Epub 2008 Apr 16.

  PMID: 18417381 BACKGROUND

• TRAUNER R, OBWEGESER H. The surgical correction of mandibular prognathism and retrognathia with consideration of genioplasty. II. Operating methods for microgenia and distoclusion. Oral Surg Oral Med Oral Pathol. 1957 Sep;10(9):899-909. doi: 10.1016/s0030-4220(57)80041-3. No abstract available.

  PMID: 13465100 BACKGROUND

• Bell WH, Schendel SA. Biologic basis for modification of the sagittal ramus split operation. J Oral Surg. 1977 May;35(5):362-9.

  PMID: 403263 BACKGROUND

• Wyatt WM. Sagittal ramus split osteotomy: literature review and suggested modification of technique. Br J Oral Maxillofac Surg. 1997 Apr;35(2):137-41. doi: 10.1016/s0266-4356(97)90691-4.

  PMID: 9146874 BACKGROUND

• Joss CU, Vassalli IM. Stability after bilateral sagittal split osteotomy advancement surgery with rigid internal fixation: a systematic review. J Oral Maxillofac Surg. 2009 Feb;67(2):301-13. doi: 10.1016/j.joms.2008.06.060.

  PMID: 19138603 BACKGROUND

• Epker BN, Wessberg GA. Mechanisms of early skeletal release following surgical advancement of the mandible. Br J Oral Surg. 1982 Sep;20(3):175-82. doi: 10.1016/s0007-117x(82)80035-8.

  PMID: 6958313 BACKGROUND

• Worms FW, Speidel TM, Bevis RR, Waite DE. Posttreatment stability and esthetics of orthognathic surgery. Angle Orthod. 1980 Oct;50(4):251-73. doi: 10.1043/0003-3219(1980)0502.0.CO;2.

  PMID: 6935978 BACKGROUND

• Angle AD, Rebellato J, Sheats RD. Transverse displacement of the proximal segment after bilateral sagittal split osteotomy advancement and its effect on relapse. J Oral Maxillofac Surg. 2007 Jan;65(1):50-9. doi: 10.1016/j.joms.2005.11.117.

  PMID: 17174764 BACKGROUND

• Nebbe B, Brooks SL, Hatcher D, Hollender LG, Prasad NG, Major PW. Interobserver reliability in quantitative MRI assessment of temporomandibular joint disk status. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Dec;86(6):746-50. doi: 10.1016/s1079-2104(98)90215-3.

  PMID: 9868736 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 17, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)