A New Treatment Protocol for Paediatric Mandibular Condylar Fractures
Primary Purpose
Fractures
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mandibular manipulation technique
Sponsored by
About this trial
This is an interventional treatment trial for Fractures focused on measuring Children, mandible, condylar fracture, conservative treatment, functional treatment
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
Sites / Locations
- Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
Patients are treated with the mandibular manipulation technique termly and mouth opening training
Outcomes
Primary Outcome Measures
Percentage of Participants with accepted anatomical and functional recovery
"accepted anatomical and functional recover" was defined as follow:
the maximal mouth opening is more than 32 millimeter
the fractured condylar with complete remodeling
No joint pain, clicking of the TMJ, and opening deviation(Normal mandibular movement without pathologic deviation was defined as lateral sliding less than 5 millimeter out of the midline of face during opening), unacceptable malocclusion(accepted occlusion is defined as stable intercuspidation between dental arches), dietary limitation was detected.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02237040
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures
Keywords
Children, mandible, condylar fracture, conservative treatment, functional treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Patients are treated with the mandibular manipulation technique termly and mouth opening training
Intervention Type
Procedure
Intervention Name(s)
Mandibular manipulation technique
Intervention Description
patients are treated with The mandibular manipulation technique reported by Farrar, which was an effective treatment method to reset the physiological positional relationship between condyle and disc.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 close back to the intercuspal position again.
Primary Outcome Measure Information:
Title
Percentage of Participants with accepted anatomical and functional recovery
Description
"accepted anatomical and functional recover" was defined as follow:
the maximal mouth opening is more than 32 millimeter
the fractured condylar with complete remodeling
No joint pain, clicking of the TMJ, and opening deviation(Normal mandibular movement without pathologic deviation was defined as lateral sliding less than 5 millimeter out of the midline of face during opening), unacceptable malocclusion(accepted occlusion is defined as stable intercuspidation between dental arches), dietary limitation was detected.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang zhiguang, master
Phone
8602083870387
Email
kouqiangzzg@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhang zhiguang, master
Organizational Affiliation
UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
Official's Role
Study Chair
Facility Information:
Facility Name
Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
City
Guang Zhou
State/Province
Guangdong
ZIP/Postal Code
510055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang zhiguang, master
Phone
8602083870387
Email
kouqiangzzg@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhang zhiguang, master
12. IPD Sharing Statement
Learn more about this trial
A New Treatment Protocol for Paediatric Mandibular Condylar Fractures
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