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Tricalcium Phosphate and Chitosan as Bone Regenerator Versus Autologous Graft in Surgery for Mandibular Fracture

NCT02081885 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-03

No results posted yet for this study

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

Conditions

  • Mandibular Fractures

Interventions

PROCEDURE

Tricalcium Phosphate / Chitosan

PROCEDURE

Autologous Graft

Sponsors & Collaborators

  • Hospital Civil de Guadalajara

    collaborator OTHER

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Alejandro Gonzalez-Ojeda, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-01-31
Completion
2017-01-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02081885 on ClinicalTrials.gov