Fracture of Condylar ProcessNCT01851031
A New Surgical Approach to Treat Medial or Low Condylar Fractures
A study testing the minor approach in people with Fracture of Condylar Process, run by West China College of Stomatology at 1 site in China.
Trial summary
The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear. Read more about this study
- Who is it for?
- Ages 5 to 56 years
- Conditions the study is for
- Fracture of Condylar Process
- What is being tested?
- the minor approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Jun 2012
- 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 5 to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (1)clinical and imaging diagnosis of medial or low condylar fractures
- (2)bone fragments that were obviously dislocated, that affected patients appearance and function, requiring surgical intervention
- (3)no previous surgical treatment
Who cannot join
- (1)medial or low condylar fractures without obvious displacement
- (2)patients who had previously undergone unsuccessful surgery
- (3)the surgical site had traumatic scar, so the approach could be carried out on the original incision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Surgical Approach to Treat Medial or Low Condylar Fractures:The Minor Parotid Anterior Approach
The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.
Read the detailed description
Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior approach, and the other 24 patients (30 sides) were treated with retromandibular approach. The data about the operations and complications were recorded. The follow-up periods were 3-12 months.
- Conditions
- Fracture of Condylar Process
- Being tested
- the minor approach
- Keywords
- medial or low condylar fractures, the minor parotid anterior approach, the retromandibular approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the minor approachProcedure or surgery
Also called the minor parotid anterior approach
Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
| Study group | Role | What they receive |
|---|---|---|
| the minor approach group | Experimental | Thirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach Receives: Procedure: the minor approach |
| control group | Other | 24 patients (control group) were treated with the retromandibular approach Receives: Procedure: the minor approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of participants with facial nerve injury
to explore whether the minor parotid anterior approach could prevent facial nerve injury.
Measured: from 3 months to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fracture of Condylar ProcessStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China College of Stomatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hou Jia, West China College of Stomatology
- Investigators
- Jia Hou, DMD, Study chair, West China College of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851031
- Sponsor's protocol ID
- houjia
- Status last verified
- May 2013
- First submitted
- 27 Apr 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang W, Gao C, Long J, Lin Y, Wang H, Liu L, Tian W. Application of modified retromandibular approach indirectly from the anterior edge of the parotid gland in the surgical treatment of condylar fracture. J Oral Maxillofac Surg. 2009 Mar;67(3):552-8. doi: 10.1016/j.joms.2008.06.066.
PubMed 19231779Hou J, Chen L, Wang T, Jing W, Tang W, Long J, Tian W, Liu L. A new surgical approach to treat medial or low condylar fractures: the minor parotid anterior approach. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Mar;117(3):283-8. doi: 10.1016/j.oooo.2013.11.491. Epub 2013 Nov 18.
PubMed 24405647
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Surgical Approach to Treat Medial or Low Condylar Fractures:The Minor Parotid Anterior Approach
- ClinicalTrials.gov ID
- NCT01851031
- Acronym / sponsor ID
- houjia
- Conditions
- Fracture of Condylar Process
- Keywords
- medial or low condylar fractures, the minor parotid anterior approach, the retromandibular approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- West China College of StomatologyUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 May 2013 (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.
The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.
Detailed description
Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior approach, and the other 24 patients (30 sides) were treated with retromandibular approach. The data about the operations and complications were recorded. The follow-up periods were 3-12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the minor approach group | Experimental | Procedure: the minor approachThirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach |
| control group | Other | Procedure: the minor approach24 patients (control group) were treated with the retromandibular approach |
Who may qualify
- Ages
- 5 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- (1)clinical and imaging diagnosis of medial or low condylar fractures
- (2)bone fragments that were obviously dislocated, that affected patients appearance and function, requiring surgical intervention
- (3)no previous surgical treatment
Key exclusion criteria (3 listed)
- (1)medial or low condylar fractures without obvious displacement
- (2)patients who had previously undergone unsuccessful surgery
- (3)the surgical site had traumatic scar, so the approach could be carried out on the original incision
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 |
|---|---|---|
| the minor approachAlso: the minor parotid anterior approachThirty-six patients (the minor approach group) were treated with minor parotid anterior approach | Procedure or surgery | control group, the minor approach group |
Primary outcome
the number of participants with facial nerve injury
Time frame: from 3 months to 1 year after surgery
to explore whether the minor parotid anterior approach could prevent facial nerve injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Results publication: PubMed 19231779Tang W, Gao C, Long J, Lin Y, Wang H, Liu L, Tian W. Application of modified retromandibular approach indirectly from the anterior edge of the parotid gland in the surgical treatment of condylar fracture. J Oral Maxillofac Surg. 2009 Mar;67(3):552-8. doi: 10.1016/j.joms.2008.06.066.
- Derived from this study: PubMed 24405647Hou J, Chen L, Wang T, Jing W, Tang W, Long J, Tian W, Liu L. A new surgical approach to treat medial or low condylar fractures: the minor parotid anterior approach. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Mar;117(3):283-8. doi: 10.1016/j.oooo.2013.11.491. Epub 2013 Nov 18.
- The West China Hospital of Stomatology has long been ranked as one of the nation's top hospitals in China.Link provided by the sponsor.
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.
Jia Hou, DMD study chair
West China College of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the minor approach in people with Fracture of Condylar Process, run by West China College of Stomatology 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 May 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of participants with facial nerve injury (time frame: from 3 months to 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851031, which also lists 2 linked publications.
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 10 May 2013.