A New Treatment Protocol for Paediatric Mandibular Condylar Fractures

NCT02237040 | Unknown DMC

• 1 other identifier: SYSU-Clinical Treatment
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures

Keywords

Children; mandible; condylar fracture; conservative treatment; functional treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with accepted anatomical and functional recovery

  "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.

  up to 1 year

Study Arms (1)

treatment group

EXPERIMENTAL

Patients are treated with the mandibular manipulation technique termly and mouth opening training

Procedure: Mandibular manipulation technique

Interventions

Mandibular manipulation technique PROCEDURE

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.

treatment group

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University

Guangzhou, Guangdong, 510055, China

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• zhang zhiguang, master

  UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY

  STUDY CHAIR

Central Study Contacts

zhang zhiguang, master

CONTACT

8602083870387; kouqiangzzg@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 11, 2014
• Study Start: March 1, 2010
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2020
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

CN (1)