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Trial record 55 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

A New Treatment Protocol for Paediatric Mandibular Condylar Fractures

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ClinicalTrials.gov Identifier: NCT02237040
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
zhang zhiguang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Fractures Procedure: Mandibular manipulation technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Paediatric Mandibular Condylar Fractures Simply With a Mandibular Manipulation Technique and Mouth Opening Training
Study Start Date : March 2010
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment group
Patients are treated with the mandibular manipulation technique termly and mouth opening training
Procedure: Mandibular manipulation technique
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 Measures :
  1. Percentage of Participants with accepted anatomical and functional recovery [ Time Frame: up to 1 year ]

    "accepted anatomical and functional recover" was defined as follow:

    1. the maximal mouth opening is more than 32 millimeter
    2. the fractured condylar with complete remodeling
    3. 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.



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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237040


Contacts
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Contact: zhang zhiguang, master 8602083870387 kouqiangzzg@hotmail.com

Locations
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China, Guangdong
Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University Recruiting
Guang Zhou, Guangdong, China, 510055
Contact: Zhang zhiguang, master    8602083870387    kouqiangzzg@hotmail.com   
Principal Investigator: Zhang zhiguang, master         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: zhang zhiguang, master UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY

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Responsible Party: zhang zhiguang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02237040     History of Changes
Other Study ID Numbers: SYSU-Clinical Treatment
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by zhang zhiguang, Sun Yat-sen University:
Children
mandible
condylar fracture
conservative treatment
functional treatment

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries