Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery

NCT05522348 | Unknown DMC

• 1 other identifier: CEBD-CU-2021-10-24
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities

Conditions

Dentofacial Deformities

Keywords

Computer guided orthognathic surgery; Splintless orthognathic surgery; Patient specific osteosynthesis; stability of le fort 1 osteotomy

Outcome Measures

Primary Outcomes (1)

• Stability of the new maxillary position

  Primary outcome will be the positional stability of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 4 months postoperative CT

  4 months

Secondary Outcomes (2)

• Intra-operative time

  Intra-operative

• Patient satisfaction using Visual Analogue Scale

  3 months

Study Arms (2)

Stability of a two piece PSI deign in splintless maxillary orthognathic surgery

EXPERIMENTAL

A two piece fixation device will be used connecting the nasomaxillary and the zygomaticomaxillary buttresses on both sides

Procedure: Stability of a two piece PSI deign in splintless maxillary orthognathic surgery

Stability of a one piece PSI deign in splintless maxillary orthognathic surgery

ACTIVE COMPARATOR

A one piece fixation device will be used extending from one zygomaticomaxillary buttress to the nasomaxillary area then just below the anterior nasal spine then to the same buttresses on the other side

Procedure: Stability of a one piece PSI deign in splintless maxillary orthognathic surgery

Interventions

Stability of a two piece PSI deign in splintless maxillary orthognathic surgery PROCEDURE

two patient fitted custom made plates will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays

Stability of a two piece PSI deign in splintless maxillary orthognathic surgery

Stability of a one piece PSI deign in splintless maxillary orthognathic surgery PROCEDURE

one patient fitted custom made plate will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays

Stability of a one piece PSI deign in splintless maxillary orthognathic surgery

Eligibility Criteria

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

You may qualify if:

• Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry.
• Patient seeking definitive surgical correction and refusing orthodontic camouflage.
• Maxillary impaction, advancement and rotations.
• Highly motivated patients.
• Good oral hygiene.
• Patients willing for the surgical procedure and follow-up, with an informed consent

You may not qualify if:

• Medically compromised patients
• Uncooperative patients
• Poor oral hygiene
• Periodontal diseases
• Patients with no desire for surgical correction
• Patients with any diseases that compromise bone or soft tissue healing Patients with local pathology that interfere with the bone healing

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine

Cairo, Manial, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Shady Shaker, B.D.S.

CONTACT

+201227655079; shadymshakerr@gmail.com

Adel Aboelfotouh, PhD

CONTACT

+201018871899; a.abouelfetouh@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome assessor will be blinded to the intervention, however the primary investigator will not be blinded as he performs the surgical procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree candidate

Model Details: randomized clinical trial parallel study and control groups equal randomization positive controlled

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 31, 2022
• Study Start: September 5, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 10, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)