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Completed

NCT Number: NCT05009056

Functional Appliance for Orthognathic Surgery

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

outpatient clinic of Oral and Maxillofacial Surgery department- Cairo University

Cairo, 11553, Egypt

About this study

The aim of this study is to compare the effect of postsurgical versus presurgical computer guided functional appliance in relapse prevention after mandibular advancement surgery.

Surgical procedure:

  • Owbgeser incision will be performed to expose the buccal and lingual aspects of the ramus angle region.
  • CAD/CAM generated preoperative wafer will be placed on the lower arch dentition, the guide has an extension to guide medial, vertical, oblique cuts as well as screw holes for reference landmarks for proximal segment & tooth bearing segment.
  • Drilling of all the reference landmarks on the proximal segment and locating medial, vertical, oblique cuts.
  • Removal of guide, then BSSO is performed.
  • The final wafer is placed, the guiding hole on the proximal segment will then be realigned with the previously drilled screw holes, fixation using mono cortical screws then drilling screw holes for plate fixation.
  • Fixation of the osteotomy using 2.0 mm pre-bent mini plates.
  • A positioning screw will be added to improve stability against rotational forces.

b-Functional appliance

Postsurgical computer guided functional appliance:

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:

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.

c- Follow up

All patients will be advised to stay on a soft diet for 4-6 weeks to avoid any undue forces on the surgical site. Postoperative CT and lateral cephalogram will be obtained, immediately postoperative and 12 months later respectively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: immediately postoperative and 12 months later

    Method of Measurement: Lateral cephalogram Unit of Measurement: mm

Secondary outcomes

  1. Assessment of condylar deviation

    Time frame: immediately postoperative and 12 months later

    Method of Measurement: CT scan Unit of Measurement: mm

Other outcomes

  1. Distal segment linear deviation

    Time frame: immediately postoperative and 12 months later

    Method of Measurement: CT scan Unit of Measurement: mm

  2. Distal segment angular deviations

    Time frame: immediately postoperative and 12 months later

    Method of Measurement: CT scan Unit of Measurement: degree

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Post-surgical Stability in Mandibular Advancement Using Postsurgical Versus Presurgical Computer Guided Functional Appliance. (RANDOMIZED CLINICAL TRIAL)

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 17, 2021
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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