Mandibular FracturesNCT02466269
Treatment of Diacapitular Condylar Fractures
An observational study of Mandibular Fractures, run by Hui Li.
Trial summary
A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- The supratemporalis approach
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to May 2015
- Phase
- Observational
- 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 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with diacapitular condylar fractures
Who may be able to join
- clinical and radiographical diagnosis of DFs;
Who cannot join
- condylar fractures with undisplaced fractures;
- Fractures without the reduction of the condylar height;
- A obvious scar at the temporal region, affecting the placement of the original incision.
About this study
Official title: A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach
A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the zygomatic arch.
Read the detailed description
Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening, mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.
- Conditions
- Mandibular Fractures
- Being tested
- The supratemporalis approach
- Keywords
- Facial Nerve Injuries
- Medical subject headings
- Mandibular Fractures, Facial Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The supratemporalis approachProcedure or surgery
The supratemporalis approach was applied in treatment of diacapitular condylar fractures
| Study group | Role | What they receive |
|---|---|---|
| the preauricular approach | A classic preauricular incision was used to treat diacapitular condylar fractures Receives: Procedure: The supratemporalis approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from facial nerve function at 24 hours postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Measured: 24 hours
Change from facial nerve function at 1 week postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Measured: 1 week
Change from facial nerve function at 3 months postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Measured: 3 months
Change from facial nerve function at 6 months postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Measured: 6 months
Change from facial nerve function at 12 months postoperatively
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Mandibular FracturesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui Li
- Sponsor type
- University, hospital or other
- Collaborators
- West China College of Stomatology
- Responsible party
- Sponsor-investigator, Hui Li, West China College of Stomatology
- Investigators
- Lei Li, DMD, Study director, Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466269
- Sponsor's protocol ID
- hui_owen
- Status last verified
- Oct 2017
- First submitted
- 3 Jun 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amaratunga NA. A study of condylar fractures in Sri Lankan patients with special reference to the recent views on treatment, healing and sequelae. Br J Oral Maxillofac Surg. 1987 Oct;25(5):391-7. doi: 10.1016/0266-4356(87)90088-x.
PubMed 3478083Silvennoinen U, Iizuka T, Lindqvist C, Oikarinen K. Different patterns of condylar fractures: an analysis of 382 patients in a 3-year period. J Oral Maxillofac Surg. 1992 Oct;50(10):1032-7. doi: 10.1016/0278-2391(92)90484-h.
PubMed 1527654Chrcanovic BR, Abreu MH, Freire-Maia B, Souza LN. 1,454 mandibular fractures: a 3-year study in a hospital in Belo Horizonte, Brazil. J Craniomaxillofac Surg. 2012 Feb;40(2):116-23. doi: 10.1016/j.jcms.2011.03.012. Epub 2011 Mar 31.
PubMed 21458284Ellis E 3rd, Moos KF, el-Attar A. Ten years of mandibular fractures: an analysis of 2,137 cases. Oral Surg Oral Med Oral Pathol. 1985 Feb;59(2):120-9. doi: 10.1016/0030-4220(85)90002-7. No abstract available.
PubMed 3856795Marker P, Nielsen A, Bastian HL. Fractures of the mandibular condyle. Part 1: patterns of distribution of types and causes of fractures in 348 patients. Br J Oral Maxillofac Surg. 2000 Oct;38(5):417-21. doi: 10.1054/bjom.2000.0317.
PubMed 11010766Loukota RA, Eckelt U, De Bont L, Rasse M. Subclassification of fractures of the condylar process of the mandible. Br J Oral Maxillofac Surg. 2005 Feb;43(1):72-3. doi: 10.1016/j.bjoms.2004.08.018.
PubMed 15620780Lindahl L. Condylar fractures of the mandible. I. Classification and relation to age, occlusion, and concomitant injuries of teeth and teeth-supporting structures, and fractures of the mandibular body. Int J Oral Surg. 1977 Feb;6(1):12-21. doi: 10.1016/s0300-9785(77)80067-7.
PubMed 402318THOMA KH. Treatment of condylar fractures. J Oral Surg (Chic). 1954 Apr;12(2):112-20. No abstract available.
PubMed 13152606Zachariades N, Mezitis M, Mourouzis C, Papadakis D, Spanou A. Fractures of the mandibular condyle: a review of 466 cases. Literature review, reflections on treatment and proposals. J Craniomaxillofac Surg. 2006 Oct;34(7):421-32. doi: 10.1016/j.jcms.2006.07.854. Epub 2006 Oct 19.
PubMed 17055280Spiessl B, Schroll K. Gelenkfortsatz und gelenkkopfchenfracturen (Fractures of the condylar neck and head). Spezielle frakture und luxationslehre (Textbook of specialised fractures and dislocations) BD. I/I. Stuttgart: Thieme. 1972.
Loukota RA, Neff A, Rasse M. Nomenclature/classification of fractures of the mandibular condylar head. Br J Oral Maxillofac Surg. 2010 Sep;48(6):477-8. doi: 10.1016/j.bjoms.2009.08.036. Epub 2009 Nov 6. No abstract available.
PubMed 19896755Chrcanovic BR. Open versus closed reduction: diacapitular fractures of the mandibular condyle. Oral Maxillofac Surg. 2012 Sep;16(3):257-65. doi: 10.1007/s10006-012-0337-6. Epub 2012 Jul 28.
PubMed 22842852He D, Yang C, Chen M, Bin J, Zhang X, Qiu Y. Modified preauricular approach and rigid internal fixation for intracapsular condyle fracture of the mandible. J Oral Maxillofac Surg. 2010 Jul;68(7):1578-84. doi: 10.1016/j.joms.2009.07.076.
PubMed 20430506Hlawitschka M, Eckelt U. Assessment of patients treated for intracapsular fractures of the mandibular condyle by closed techniques. J Oral Maxillofac Surg. 2002 Jul;60(7):784-91; discussion 792. doi: 10.1053/joms.2002.33246.
PubMed 12089693Molina CV, Moreno RO, Coloma OB, Meza VD, Silva MA. Preauricular approach: our alternative for surgical treatment of condylar fractures. International Journal of Oral and Maxillofacial Surgery. 2013;42:1236
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach
- ClinicalTrials.gov ID
- NCT02466269
- Acronym / sponsor ID
- hui_owen
- Conditions
- Mandibular Fractures
- Keywords
- Facial Nerve Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hui LiUniversity, hospital or other
- Collaborators
- West China College of Stomatology
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Jun 2015 (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.
A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the zygomatic arch.
Detailed description
Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening, mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the preauricular approach | – | Procedure: The supratemporalis approachA classic preauricular incision was used to treat diacapitular condylar fractures |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with diacapitular condylar fractures
Key inclusion criteria (1 listed)
- clinical and radiographical diagnosis of DFs;
Key exclusion criteria (3 listed)
- condylar fractures with undisplaced fractures;
- Fractures without the reduction of the condylar height;
- A obvious scar at the temporal region, affecting the placement of 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 supratemporalis approachThe supratemporalis approach was applied in treatment of diacapitular condylar fractures | Procedure or surgery | the preauricular approach |
Primary outcome
Change from facial nerve function at 24 hours postoperatively
Time frame: 24 hours
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 1 week postoperatively
Time frame: 1 week
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 3 months postoperatively
Time frame: 3 months
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 6 months postoperatively
Time frame: 6 months
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 12 months postoperatively
Time frame: 12 months
The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
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 25 Oct 2017.
- Background: PubMed 3478083Amaratunga NA. A study of condylar fractures in Sri Lankan patients with special reference to the recent views on treatment, healing and sequelae. Br J Oral Maxillofac Surg. 1987 Oct;25(5):391-7. doi: 10.1016/0266-4356(87)90088-x.
- Background: PubMed 1527654Silvennoinen U, Iizuka T, Lindqvist C, Oikarinen K. Different patterns of condylar fractures: an analysis of 382 patients in a 3-year period. J Oral Maxillofac Surg. 1992 Oct;50(10):1032-7. doi: 10.1016/0278-2391(92)90484-h.
- Background: PubMed 21458284Chrcanovic BR, Abreu MH, Freire-Maia B, Souza LN. 1,454 mandibular fractures: a 3-year study in a hospital in Belo Horizonte, Brazil. J Craniomaxillofac Surg. 2012 Feb;40(2):116-23. doi: 10.1016/j.jcms.2011.03.012. Epub 2011 Mar 31.
- Background: PubMed 3856795Ellis E 3rd, Moos KF, el-Attar A. Ten years of mandibular fractures: an analysis of 2,137 cases. Oral Surg Oral Med Oral Pathol. 1985 Feb;59(2):120-9. doi: 10.1016/0030-4220(85)90002-7. No abstract available.
- Background: PubMed 11010766Marker P, Nielsen A, Bastian HL. Fractures of the mandibular condyle. Part 1: patterns of distribution of types and causes of fractures in 348 patients. Br J Oral Maxillofac Surg. 2000 Oct;38(5):417-21. doi: 10.1054/bjom.2000.0317.
- Background: PubMed 15620780Loukota RA, Eckelt U, De Bont L, Rasse M. Subclassification of fractures of the condylar process of the mandible. Br J Oral Maxillofac Surg. 2005 Feb;43(1):72-3. doi: 10.1016/j.bjoms.2004.08.018.
- Background: PubMed 402318Lindahl L. Condylar fractures of the mandible. I. Classification and relation to age, occlusion, and concomitant injuries of teeth and teeth-supporting structures, and fractures of the mandibular body. Int J Oral Surg. 1977 Feb;6(1):12-21. doi: 10.1016/s0300-9785(77)80067-7.
- Background: PubMed 13152606THOMA KH. Treatment of condylar fractures. J Oral Surg (Chic). 1954 Apr;12(2):112-20. No abstract available.
- Background: PubMed 17055280Zachariades N, Mezitis M, Mourouzis C, Papadakis D, Spanou A. Fractures of the mandibular condyle: a review of 466 cases. Literature review, reflections on treatment and proposals. J Craniomaxillofac Surg. 2006 Oct;34(7):421-32. doi: 10.1016/j.jcms.2006.07.854. Epub 2006 Oct 19.
- BackgroundSpiessl B, Schroll K. Gelenkfortsatz und gelenkkopfchenfracturen (Fractures of the condylar neck and head). Spezielle frakture und luxationslehre (Textbook of specialised fractures and dislocations) BD. I/I. Stuttgart: Thieme. 1972.
- Background: PubMed 19896755Loukota RA, Neff A, Rasse M. Nomenclature/classification of fractures of the mandibular condylar head. Br J Oral Maxillofac Surg. 2010 Sep;48(6):477-8. doi: 10.1016/j.bjoms.2009.08.036. Epub 2009 Nov 6. No abstract available.
- Background: PubMed 22842852Chrcanovic BR. Open versus closed reduction: diacapitular fractures of the mandibular condyle. Oral Maxillofac Surg. 2012 Sep;16(3):257-65. doi: 10.1007/s10006-012-0337-6. Epub 2012 Jul 28.
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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.
Lei Li, DMD study director
Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures, run by Hui Li.
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 1 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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from facial nerve function at 24 hours postoperatively (time frame: 24 hours). The study lists 5 primary outcomes in all. 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 NCT02466269, which also lists 32 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 25 Oct 2017.