CompletedPhase 3

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

Mexico24 participantsStarted 2014-01

Plain-language 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

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bone density determination in regenerated bone.

Timeframe: 30 days after the procedure.

Bone density determination in regenerated bone.

Timeframe: 6 months after the procedure.

Trial details

NCT IDNCT02081885

SponsorInstituto Mexicano del Seguro Social

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2015-01

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