Skip to content

Clinical Assessment of Computer-assisted PEEK Versus Conventional Titanium Plates on Mandibular Body Fractures

Clinical Assessment of Postoperative Occlusion in Patient With Mandibular Body Fractures Reduced and Fixed With Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Conventional Titanium Plates (RCT)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03466190
Enrollment
20
Registered
2018-03-15
Start date
2017-08-02
Completion date
2019-03-02
Last updated
2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Mandible, Mandibular Fractures

Keywords

Mandibular body fractures, PEEK plates, titanium plates.

Brief summary

Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.

Detailed description

Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates. Inclusion criteria: All subjects were required: 1. Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface. 2. All ages and both sexes were included in this study. 3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. 4. Patients with good general condition allowing major surgical procedure under general anesthesia. 5. Patients with physical and psychological tolerance. Exclusion criteria: 1. Patients with high risk systemic diseases like uncontrolled diabetes . As uncontrolled diabetes has a negative impact on normal bone healing. 2. Patients with old fractures. As they will affect accuracy of reduction of the fractured segments. 3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. Interventions: Eligible patients will be randomized in equal proportions between the study group (PEEK custom made plates) and the control group (titanium plates). A- Computer-assisted PEEK custom made plates: * All cases will undergo surgery under general anesthesia. * Exposure of the fractured segments will be done using a standardized surgical approach. * The fractured segments will be reduced in normal anatomic position guided by customized plate. * Fracture fragments will be fixed using PEEK custom made plate utilizing 2.0 mm screws. B- Conventional titanium plates: * All cases will undergo surgery under general anesthesia. * Exposure of the fractured segments will be done using a standardized surgical approach. * Inter-maxillary fixation will be done. * The fractured segments will be reduced in normal anatomic position guided by occlusion. * The fracture fragments will be fixed using 2.3 titanium plate on the inferior border and 2.0 titanium plate on the superior border utilizing bone screws. Follow up: Clinical evaluation will be performed at the first week postoperative. Computed tomography will be performed at the first week postoperative then patients will be recalled for clinical evaluation every week for one month. Final follow up visit will be at 3 months postoperative.

Interventions

PROCEDURETitanium plate fixation

Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed.

PROCEDURECustom made PEEK plate fixation

Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigator nor participants can be blinded

Intervention model description

* A Randomized clinical trial. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment. * Parallel group study: Each group of patients receives a single treatment simultaneously.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface. 2. All ages and both sexes were included in this study. 3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. 4. Patients with good general condition allowing major surgical procedure under general anesthesia. 5. Patients with physical and psychological tolerance.

Exclusion criteria

1. Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health. 2. Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing. 3. Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments. 4. Patient with bad oral hygiene. As it has an influence on normal osseous healing

Design outcomes

Primary

MeasureTime frameDescription
Postoperative occlusion1 month postoperativeRestoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10)

Secondary

MeasureTime frameDescription
Accuracy of the planned reduction1st weekThe accuracy of computer assisted PEEK custom made plates in open reduction and internal fixation of mandibular body fractures will be assessed using Mimics software, measuring unit (mm)
Wound dehiscence1 month postoperativeWound infection will be assessed via clinical assessment, measuring unit (Binary yes/no)
The need for 2nd surgery1 month postoperativeRedo surgery will be assessed via clinical assessment, measuring unit (Binary yes/no)
Operative timeDuring operationSurgical time will be assessed via clinical assessment, measuring unit (hours)

Countries

Egypt

Contacts

Primary ContactRofaida A Ahmad, MSc
ro_fy_at@yahoo.com+201099669299
Backup ContactRofaida A Ahmad, MSc
rofaidaatef14@gmail.com+201099669299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026