Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism

NCT03855072 | Unknown DMC

• 1 other identifier: Goal NO 5 , OMFS IV A3
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Two groups with mandibular prognanthism indicated for mandibular setback by intraoral vertical ramus osteotomy . first group will fixed with maxillomandibular fixation and the second group will fixed by customized plate

Conditions

Mandibular Prognathism

Keywords

Mandibular Prognanthism,customized plate

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Patient were asked to fill out a questionnaire in order to investigate their satisfaction degree after surgery ,according to an adapted (10 cm) visual analogue scale (VAS) from 0 to +10 0 is the least satisfied 10 is the most satisfied

  immediately postoperative

Secondary Outcomes (1)

• stability of Mandible

  pre- operative , 2 weeks postoperative , 2 months postoperative , 6 months postoperative

Study Arms (2)

Customized plate fixation

EXPERIMENTAL

Customized Plate fixation of Vertical Ramus Osteotomy after Mandibular Setback \- intervention: * All cases will undergo one surgery under general anesthesia. * Incision was made medial to external oblique ridge from the asendindg ramus to second molar region * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS * The customized fixation plate is positioned to fix the proximal and distal segment together

Procedure: customized fixation plate

maxillomandibular fixation

ACTIVE COMPARATOR

Mandibular Setback by Vertical Ramus Ostotmy fixed with Maxillomandibular fixation \- intervention: * All cases will undergo one surgery under general anesthesia * incision was made medial to external oblique ridge from the asendindg ramus to second molar region . * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint

Procedure: maxillomandibular fixation

Interventions

customized fixation plate PROCEDURE

* All cases will undergo one surgery under general anesthesia. * Incision was made medial to external oblique ridge from the asendindg ramus to second molar region * Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * 3D virtual planning and 3D mandible model represented fom CBCT in MIMICS * The customized fixation plate is positioned to fix the proximal and distal segment together after setback

Also known as: patient specific osteosynthesis

Customized plate fixation

maxillomandibular fixation PROCEDURE

* All cases will undergo one surgery under general anesthesia. * incision was made medial to external oblique ridge from the asendindg ramus to second molar region . * The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible. * Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position.

Also known as: intermaxillary fixation

maxillomandibular fixation

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects were required:
• Patients with mandibular prognanthism indicated for mandibular setback.
• All ages \>18 years
• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
• Patients with good general condition allowing surgical procedure under general anesthesia.
• Patients with physical and psychological tolerance

You may not qualify if:

• History of mandibular trauma
• Previous orthognathic surgery
• Degenerative disease of temporomandibular joint
• Craniofacial syndrome such as cleft lip or palate
• Follow up period will be less than 6 months

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Malocclusion, Angle Class III

Interventions

Jaw Fixation Techniques

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate lecturer

Model Details: * A Randomized Controlled Trial * A Trial will be carried out in Hospital of Oral and Maxillofacial surgery departement- faculty of Dentistry , Cairo University * Equal randomization : participant with equal probabilities for intervention * Parallel group study : Each group of patients recieves a single treatment simultaneously

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 26, 2019
• Study Start: June 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 26, 2019

Record last verified: 2019-02