A New Treatment Protocol for Paediatric Mandibular Condylar Fractures

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02237040
Collaborator
(none)
80
1
1
120
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Mandibular manipulation technique
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
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 :
Mar 1, 2010
Anticipated Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants with accepted anatomical and functional recovery [up to 1 year]

    "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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University Guang Zhou Guangdong China 510055

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Study Chair: zhang zhiguang, master, UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
zhang zhiguang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02237040
Other Study ID Numbers:
  • SYSU-Clinical Treatment
First Posted:
Sep 11, 2014
Last Update Posted:
May 20, 2015
Last Verified:
May 1, 2015
Keywords provided by zhang zhiguang, Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2015