FracturesNCT02237040
A New Treatment Protocol for Paediatric Mandibular Condylar Fractures
A study testing Mandibular manipulation technique in people with Fractures, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Fractures
- What is being tested?
- Mandibular manipulation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- suffer mandibular condylar fracture
- voluntary Patient
- with no concomitant displaced jaw fractures
- the fracture-treatment interval time is less than 2 months
Who cannot join
- Life-threatening Patient
- Patient can not do the Guide Line
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guanghua School of Stomatology, Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, 510055
Zhang zhiguang, master, 8602083870387, kouqiangzzg@hotmail.com
Zhang zhiguang, master
About this study
Official title: Management of Paediatric Mandibular Condylar Fractures Simply With a Mandibular Manipulation Technique and Mouth Opening Training
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.
Read the 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.
- Conditions
- Fractures
- Being tested
- Mandibular manipulation technique
- Keywords
- Children, mandible, condylar fracture, conservative treatment, functional treatment
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular manipulation techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Patients are treated with the mandibular manipulation technique termly and mouth opening training Receives: Procedure: Mandibular manipulation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startMar 2010
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhang zhiguang, Sun Yat-sen University
- Investigators
- zhang zhiguang, master, Study chair, UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237040
- Sponsor's protocol ID
- SYSU-Clinical Treatment
- Status last verified
- May 2015
- First submitted
- 29 Aug 2014
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Paediatric Mandibular Condylar Fractures Simply With a Mandibular Manipulation Technique and Mouth Opening Training
- ClinicalTrials.gov ID
- NCT02237040
- Acronym / sponsor ID
- SYSU-Clinical Treatment
- Conditions
- Fractures
- Keywords
- Children, mandible, condylar fracture, conservative treatment, functional treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: Mandibular manipulation techniquePatients are treated with the mandibular manipulation technique termly and mouth opening training |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- suffer mandibular condylar fracture
- voluntary Patient
- with no concomitant displaced jaw fractures
- the fracture-treatment interval time is less than 2 months
Key exclusion criteria (2 listed)
- Life-threatening Patient
- Patient can not do the Guide Line
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular manipulation techniquepatients 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. | Procedure or surgery | treatment group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhang zhiguang, master study chair
UANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular manipulation technique in people with Fractures, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang zhiguang, master (8602083870387, kouqiangzzg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with accepted anatomical and functional recovery (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.