NCT02081885

Brief Summary

Introduction After a mandibular fracture where bone has been lost, a number of complications and challenges are presented in trying to solve them. These defects are mainly classified into two groups: functional and cosmetic. The functional defects are incompetence of the lower lip, salivary incontinence, severe difficulty chewing and swallowing, temporomandibular joint disorders and difficulty in pronouncing words. Esthetically facial asymmetry is produced with collapse of the affected side. Unreconstructed jaw retrusion and tends to offset the affected side, there is a change in mandibular movements, which, previous vertical movements are replaced by oblique or diagonal movements controlled by a single temporomandibular joint. It also presents a limitation in motility and lingual force, besides proprioception disorder left by the inferior alveolar nerve The loss of bone in mandibular fractures, is one of the great challenges facing maxillofacial surgery and unfortunately increasingly common. That's why they have done and are still doing research for the development of biomaterials, all with the purpose of trying to solve this problem by offering the patient better results than those obtained in the past, restoring both function and facial aesthetics according to each case

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

January 31, 2014

Last Update Submit

September 29, 2023

Conditions

Mandibular Fractures

Keywords

Tricalcium phosphateChitosanGrafting, BoneMandibular Fractures

Outcome Measures

Primary Outcomes (2)

  • Bone density determination in regenerated bone.

    Determined with computed tomography measure by using Hounsfield Units.

    30 days after the procedure.

  • Bone density determination in regenerated bone.

    Determined with computed tomography measure by using Hounsfield Units.

    6 months after the procedure.

Secondary Outcomes (11)

  • Classification of mandibular fracture

    One day before surgery

  • Edema

    Patients will be followed daily from the immediate postoperative period until discharge, an expected average of 3 days.

  • Postoperative infection.

    Patients will be followed daily from the immediate postoperative period until discharge, an expected average of 3 days.

  • Defect Size

    30 days after the procedure.

  • Edema

    8 days after procedure.

  • +6 more secondary outcomes

Other Outcomes (2)

  • Age

    One day before surgery

  • Gender

    One day before surgery

Study Arms (2)

Tricalcium Phosphate / Chitosan

EXPERIMENTAL
Procedure: Tricalcium Phosphate / Chitosan

Autologous Graft

ACTIVE COMPARATOR
Procedure: Autologous Graft

Interventions

Tricalcium Phosphate / ChitosanPROCEDURE
Tricalcium Phosphate / Chitosan
Autologous GraftPROCEDURE
Autologous Graft

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients ot the service of reconstructive and plastic surgery of the Civil Hospital in Guadalajara Fray Antonio Mayor, with a diagnosis of traumatic mandibular fracture with bone defect \< 2.5 cm.
  • Wishing to participate in the study

You may not qualify if:

  • Patients who have undergone radiation therapy.
  • Psychiatric Patients.
  • Patients who have not signed informed consent.
  • Patients with Diabetes
  • Patients with alterations in bone metabolism
  • Patients with kidney diseases
  • Patients who receipt corticosteroids
  • Patients with heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Civil Hospital of Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Conditions

Mandibular Fractures

Interventions

tricalcium phosphateChitosanTransplantation, Autologous

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ChitinBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTransplantationSurgical Procedures, Operative

Study Officials

  • Alejandro Gonzalez-Ojeda, PhD

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 31, 2014

First Posted

March 7, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2017

Last Updated

October 3, 2023

Record last verified: 2023-09

Locations

ME(1)