Clinical trial NCT02237040: A New Treatment Protocol for Paediatric Mandibular Condylar Fractures
Official title: Management of Paediatric Mandibular Condylar Fractures Simply With a Mandibular Manipulation Technique and Mouth Opening Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fractures
Keywords: Children
mandible
condylar fracture
conservative treatment
functional treatment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 80
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* suffer mandibular condylar fracture
* voluntary Patient
* with no concomitant displaced jaw fractures
* the fracture-treatment interval time is less than 2 months

Exclusion Criteria:

* Life-threatening Patient
* Patient can not do the Guide Line

Primary outcomes:
measure: Percentage of Participants with accepted anatomical and functional recovery
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guang Zhou
country: China
facility: Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
name: zhang zhiguang, master
role: STUDY_CHAIR
References: