A New Treatment Protocol for Paediatric Mandibular Condylar Fractures

Status Recruiting

Clinical Trial Summary

This study aim to evaluate the clinical and radiographic outcomes of mandibular condylar fractures in pediatrics treated simply with a mandibular manipulation technique accompanied by mouth opening training.

Clinical Trial Description

There is a consensus on nonsurgical approach is a priority for paediatric condylar fractures, but a recognized nonsurgical method for treating children with condylar fractures is still a highly debated theme. The purpose of this study is to investigate the effect of a new nonsurgical method simply using a mandibular manipulation technique and mouth opening training in managing children with condylar fractures.

Spiral computed tomography (CT) or Cone beam computed tomography (CBCT) will be taken before treatment when the patients present to the department. Condylar fracture classification is defined according to SPIESSL & SCHROLL.

These patients are then treated termly with a mandibular manipulation technique reported by Farrar, which is an effective treatment method to reset the physiological positional relationship between condyle and disc. Neither intermaxillary fixation nor guiding elastics will be used after hand manipulation. Then patients are told to persist in mouth opening training at home everyday. The mouth opening training is performed as follow: patients are told to try to close his mouth in intercuspal position at first, then open their mouth as wide as possible(the reference maximal mouth opening is as wide as the mouth opening after treatment in last time), then closed back to the intercuspal position again. Patients are recommended to follow up at every week at first two months, then every 2 weeks at third months, 6th months, 1 year after first treatment, then yearly afterward. The mandibular manipulation is performed at every follow-up. Meanwhile, the maximal mouth opening (MMO) is recorded before and after hand manipulation treatment. So do the occlusion status, deviation during opening, as well as subjective symptoms of temporomandibular joints. At first moth, 3rd month, 6th month, 1 year, then every year after first treatment, CBCT is performed. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02237040
Study type	Interventional
Source	Sun Yat-sen University
Contact	zhang zhiguang, master
Phone	8602083870387
Email	kouqiangzzg@hotmail.com
Status	Recruiting
Phase	N/A
Start date	March 2010
Completion date	March 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00137085` - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation	N/A
Completed	`NCT00152321` - Strategies Targeting Osteoporosis to Prevent Recurrent Fractures	N/A
Completed	`NCT00235404` - Randomized Controlled Trial of Health Care to Elderly Patients.	N/A
Completed	`NCT01127711` - Cohort of Swedish Men	N/A
Completed	`NCT00060970` - Evaluating Muscle Function After Ankle Surgery	N/A
Completed	`NCT02576730` - Functional Outcome Assessment After (Calcaneal) Trauma Surgey	N/A
Completed	`NCT02074969` - Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures	N/A
Completed	`NCT00767780` - The Effect of a New Biomechanical Device	N/A
Withdrawn	`NCT00355420` - Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures.	Phase 2
Completed	`NCT00129142` - Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy	Phase 3
Terminated	`NCT03367169` - Surgery of the Pilon Fractures	N/A
Active, not recruiting	`NCT01452243` - Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial	Phase 3
Completed	`NCT00545350` - Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study	N/A
Terminated	`NCT00387686` - A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures	Phase 2/Phase 3
Completed	`NCT02292316` - Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility	N/A
Completed	`NCT01136616` - CT Analysis of Structural Buttresses in the Traumatised Nose	Phase 2
Completed	`NCT02090972` - The Impact of Opioids in Fractures - a Case Control Study	N/A
Completed	`NCT00872105` - Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle	N/A
Completed	`NCT00652548` - Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients	N/A
Completed	`NCT00079521` - Therapeutic Touch for Wrist Fractures in Postmenopausal Women	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.