Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates

NCT ID: NCT03839368

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2021-04-30

Brief Summary

In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.

Detailed Description

In the past two decades, rigid internal fixation with miniplate has become the standard treatment modality in the management of mandibular fracture.

The optimal management of mandibular angle fractures remains controversial, thus continuous experimental & clinical studies are being conducted to determine the best miniplate design which will provide the best postoperative stability & resistance to mechanical function.

Since Michelet et al.& Champy et al. recommended the use of a single (4-6 holes) monocortical plate , it become an acceptable method for angle fractures fixation.

Several surgeons have documented low complication rates with (Champy technique).But, according to the most recent experimental & clinical studies, the stability provided by the miniplate fixation has become a point of debate among surgeons.Many researchers have argued that internal fixation with a passive miniplate along the external oblique line, following Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a failure of osteosynthesis & gap at inferior border of the mandible.And that pushed researches to conduct more studies to evaluate many plate & screw systems and even suggest new designs for better stable postoperative results.

In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one straight section and two lateral extensions. The straight section of this new design, which has four holes, was adapted to the superior border of the external oblique ridge & provides similar advantages to the Champy technique (an intraoral approach, a single miniplate, & the use of monocortical screws) .And the two lateral extensions, with one hole each, were then bent over to adapt to the buccal cortex of the ascending ramus along the external oblique ridge to resist lateral & torsional forces.

Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in this study owing to the similarities in size & thickness to the human mandible. All of the mandibles were stripped of their soft tissues & sectioned through the midline, between the central incisors. 30 hemimandibles were randomly divided into two groups , these groups were then fixed with two different plating techniques (the new design & one conventional miniplates). And they were all examined for stability and resistance to mechanical forces (vertical, lateral, or tensile).

The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages & simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. These findings are correlated to those of in vitro biomechanical study done by Alkan et al. that showed that Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D strut plate. In addition the new plate provide greater stability when subjected to lateral displacing forces.

More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.

Conditions

Mandible Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

K plate

fixation of angle fracture using K plate versus two miniplates

Group Type: EXPERIMENTAL

fixation of angle fracture

Intervention Type: PROCEDURE

open reduction and internal fixation of angle fracture

Conventional two miniplates

fixation of angle fracture using K plate versus two miniplates

Group Type: ACTIVE_COMPARATOR

fixation of angle fracture

Intervention Type: PROCEDURE

open reduction and internal fixation of angle fracture

Interventions

fixation of angle fracture

open reduction and internal fixation of angle fracture

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with unilateral angle fracture.

2. Patients free from any systemic disease & bone metabolism diseases.

3. No sex predilection

4. Age range ( 15-70)

Exclusion Criteria

1. Comminuted fragmented & infected angle fractures.

2. Bilateral angle fracture.

3. Systemic diseases.

4. bone metabolism diseases

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hagar Mahmoud Ahmed Mohamed

Resident of Oral and Maxillofacial Surgery - Nasser Institute Hospital for research & treatment / Master Candidate of Oral & Maxillofacial surgery, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hagar Mohamed, BDS

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Hagar A Mohamed, BDS

Role: CONTACT

hagar_elsherif92@yahoo.com

01016799911

References

Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.

Reference Type: BACKGROUND

PMID: 24582290 (View on PubMed)

El-Sherif HM, Ali S, Talaat M, Mubarak F. Stability and Clinical Outcomes of Angle Fracture Fixation Using Sagittal Split Plate (SSOP) Versus Two Miniplates: Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Feb;23(1):107-113. doi: 10.1007/s12663-022-01817-z. Epub 2022 Nov 16.

Reference Type: DERIVED

PMID: 38312972 (View on PubMed)

Other Identifiers

CEBD-CU-2019-02-03

Identifier Type: -

Identifier Source: org_study_id