Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

NCT03640039 | Unknown DMC

• 1 other identifier: 2972018
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.

Conditions

Mandible Fracture

Keywords

3d strut plate; mandibular angle fracture

Outcome Measures

Primary Outcomes (1)

• stability of fracture segments.

  post operative bimanual manipulation of the fracture segment.

  15 days post operative.

Secondary Outcomes (2)

• inferior alveolar nerve injury.

  pre operative and 1 week post operative.

• Accuracy of fracture reduction.

  one week post operative.

Study Arms (2)

study group: 3d strut plate fixation without post op IMMF.

EXPERIMENTAL

Open reduction and internal fixation with 3d strut plate without post operative IMMF.

Procedure: 3d strut plate.

control group: 3d srut plate fixation with post op IMMF.

ACTIVE COMPARATOR

Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days.

Procedure: 3d strut plate.

Interventions

3d strut plate. PROCEDURE

Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.

control group: 3d srut plate fixation with post op IMMF.; study group: 3d strut plate fixation without post op IMMF.

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible.
• Patient over 15 years old age and both sexes were included in this study.
• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
• Patients with good general condition allowing major surgical procedure under general anesthesia.
• Patients with physical and psychological tolerance.

You may not qualify if:

• Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate .
• Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
• Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (8)

• Kellman RM. Repair of mandibular fractures via compression plating and more traditional techniques: a comparison of results. Laryngoscope. 1984 Dec;94(12 Pt 1):1560-7.

  PMID: 6503575 BACKGROUND

• Saman M, Kadakia S, Ducic Y. Postoperative maxillomandibular fixation after open reduction of mandible fractures. JAMA Facial Plast Surg. 2014 Nov-Dec;16(6):410-3. doi: 10.1001/jamafacial.2014.543.

  PMID: 25232835 BACKGROUND

• Guimond C, Johnson JV, Marchena JM. Fixation of mandibular angle fractures with a 2.0-mm 3-dimensional curved angle strut plate. J Oral Maxillofac Surg. 2005 Feb;63(2):209-14. doi: 10.1016/j.joms.2004.03.018.

  PMID: 15690289 BACKGROUND

• Farmand M. [Experiences with the 3-D miniplate osteosynthesis in mandibular fractures]. Fortschr Kiefer Gesichtschir. 1996;41:85-7. German.

  PMID: 8755408 BACKGROUND

• Vineeth K, Lalitha RM, Prasad K, Ranganath K, Shwetha V, Singh J. "A comparative evaluation between single noncompression titanium miniplate and three dimensional titanium miniplate in treatment of mandibular angle fracture"--a randomized prospective study. J Craniomaxillofac Surg. 2013 Mar;41(2):103-9. doi: 10.1016/j.jcms.2012.05.015. Epub 2012 Jul 17.

  PMID: 22809633 BACKGROUND

• Farmand M, Dupoirieux L. [The value of 3-dimensional plates in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1992;93(6):353-7. French.

  PMID: 1475603 BACKGROUND

• Sadhwani BS, Anchlia S. Conventional 2.0 mm miniplates versus 3-D plates in mandibular fractures. Ann Maxillofac Surg. 2013 Jul;3(2):154-9. doi: 10.4103/2231-0746.119231.

  PMID: 24205475 BACKGROUND

• Jain MK, Manjunath KS, Bhagwan BK, Shah DK. Comparison of 3-dimensional and standard miniplate fixation in the management of mandibular fractures. J Oral Maxillofac Surg. 2010 Jul;68(7):1568-72. doi: 10.1016/j.joms.2009.07.083. Epub 2010 Apr 22.

  PMID: 20417012 BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Hesham A Hakam, Prof

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed T khater, MSc

CONTACT

+201003854552; m_khater385@yahoo.com

Study Design

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

Model Details: * A Radomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of oral and maxillofacial surgery department - faculty of dentistry cairo university. * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: both groups receiving treatment.

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 21, 2018
• Study Start: January 11, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share