Intra-articular Fracture of the Mandibular CondyleFIACNCT04776473
Treatment of Intra-articular Fractures of the Mandibular Condyle
A study testing Open treatment and Closed treatment in people with Intra-articular Fracture of the Mandibular Condyle, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Intra-articular Fracture of the Mandibular Condyle
- What is being tested?
- Open treatment and Closed treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 7 sitesFrance
- Study dates
- 3 May 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 y-o) < 85 years
- Displaced non-comminuted intra-articular fracture of the mandibular condyle (IAFC) as defined by a fracture line above a horizontal line tangent to the mandibular notch
- Objectifiable induced malocclusion and/or ramus shortening ≥2 mm on CT-scan (a ramus shortening ≥2 mm on CT-scan is necessary in case of other associated mandibular or occluso-facial fractures)
- Unilateral or bilateral fracture
- Isolated or associated with other facial / extra-facial skeleton / dental / soft tissue lesions
- Treatment within 14 days post trauma
- Affiliation to a social security regime (excepted AME)
- Written informed consent
Who cannot join
- Contraindication to surgical treatment (for any medical or anatomical reason, like comminuted fracture for instance)
- Major teeth loss or edentulous patient (occlusion impossible to assess)
- History of mandibular fracture
- History of temporo-mandibular joint (TMJ) disorder
- Dentofacial dysmorphosis causing significant malocclusion
- Predictable inability to comply with the follow-up
- Unconsciousness / severe polytrauma
- Participation in another interventional study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CHU Angers
Angers
- Not yet recruiting
Hôpital Annecy Genevois
Annecy, 74370
- Not yet recruiting
APHM - Hôpital de la Conception
Marseille, 13005
- Not yet recruiting
CHU de Nantes
Nantes, 44093
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Thomas SCHOUMAN, MD, PhD, (0)1 42 16 13 01 ext. +33, thomas.schouman@aphp.fr
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67200
- Not yet recruiting
CHU Purpan - Hôpital Pierre-Paul Riquet
Toulouse, 31300
About this study
Official title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. During the last 15 years, a growing interest has emerged for open (surgical) treatment of these fractures. Although there is more and more evidence suggesting that the open treatment may be the treatment of choice for selected cases of subcondylar fractures, the best option remains controversial for high condylar fractures.
The primary objective of the trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.
This study is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.
Read the detailed description
The mandibular condyle is one of the most frequent locations of facial fractures. It can lead to severe functional impairment if the occlusion is not properly restored and the mandibular mobility not recovered totally or within an acceptable range. Most frequent sequels of these fractures include limitation of mandibular movements resulting in limited mouth opening, occlusal disturbance causing chewing malfunction, chronic pain, chronic temporo-mandibular joint (TMJ) disorder and facial asymmetry. The risk of permanent limited mouth opening is even higher when the fracture is located inside the TMJ. Although the superiority of surgical treatment is now widely accepted for low-level fractures of the condylar unit (i.e., extra-articular fractures) the treatment of fractures involving the TMJ in adult patients is still controversial.
Treatment principles in these fractures can be ranked in two groups: closed and open treatments. Closed treatment - also called closed reduction or conservative treatment - consists in prolonged physical therapy frequently associated with transient maxillo-mandibular fixation (MMF). Open treatment consists in open reduction and internal fixation of the fracture (ORIF).
No randomized controlled trial has ever evaluated the superiority of open versus closed treatment, and treatment strategy for IAFC remains a matter of ongoing debate.
The primary objective of this trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.
The secondary objectives are to compare between open (surgical) and closed (conservative) treatments:
At 3 weeks, 6 weeks, 3 months, 6 months, and 12 months post-treatment:
- maximal mouth opening (in mm)
- maximal mandibular protrusion (in mm),
- maximal lateral excursion (in mm),
- lateral deviation of the mandible during mouth opening
- occlusal disturbance evaluated by both the patient and the surgeon
- pain using a visual analog scale
- subjective functional impairment as assessed by the Mandibular Function Impairment Questionnaire
Overall:
- duration of sick leave
- time to normal activity recovery (social activities, eating, sports) We will also evaluate compliance with the intervention. This trial is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.
- Being tested
- Open treatment, Closed treatment
- Keywords
- intra-articular fracture, mandibular condyle, surgical treatment, conservative treatment
- Medical subject headings
- Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open treatmentProcedure or surgery
Also called Surgical treatment
Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
Closed treatmentOther
Also called Conservative treatment
Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
| Study group | Role | What they receive |
|---|---|---|
| Open (i.e. surgical) treatment | Experimental | This includes reduction and internal fixation of the fracture (ORIF) performed using the preferred surgical approach and bone implants of the including centre that could be associated with one or several items among the following:
* physical therapy based on exercises done by the patient himself
* physical therapy performed by a specialized/non-specialized physical therapist
* arch bars / screws / splint use for transient MMF
* arch bars / screws / splint use for passive mobilization of the mandible Receives: Procedure: Open treatment |
| Closed (i.e. conservative) treatment | Other | To date, there is no consensus on which procedures should be used in case of conservative treatment, which may vary between centres and, for a same centre, between patients. This includes one or several items among the following:
* physical therapy based on exercises done by the patient himself
* physical therapy performed by a specialized/non-specialized physical therapist
* arch bars / screws / splint use for transient maxillo-mandibular fixation (MMF) (15 days max)
* arch bars / screws / splint use for passive mobilization of the mandible Receives: Other: Closed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal mouth opening (in mm) at 3 months
It will be obtained by measuring the interincisal distance at maximum mouth opening with a caliper or a ruler. The patient will be first asked to open the mouth as widely as possible for 3 seconds and to rest for 5 seconds. This sequence will be repeated 2 times and at the third repetition the patient will keep his/her mouth opened while the physician will measure inter-incisal distance
Measured: 3 months (+/-10 days)
Secondary outcomes (16)
Maximal mouth opening (in mm)
Measured following the method described for primary outcome.
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Maximal mandibular protrusion (in mm)
- Maximal mandibular protrusion in mm measured with a caliper or with a ruler, asking the patient to move the mandible as far as possible in the forward direction while keeping a slight contact between the dental arches. This measure will be done only after repetition of mouth opening and measurement of the maximum mouth opening, which will warm up mandibular mobilization
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Maximal lateral excursion (in mm)
Maximal lateral excursion in mm measured with a caliper or with a ruler, asking the patient to move the mandible as far as possible in the right and left directions while keeping a slight contact between the dental arches. These measurements will be done only after repetition of mouth opening and measurement of the maximum mouth opening, which will warm up mandibular mobilization
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Lateral deviation of the mandible during mouth opening
Lateral deviation of the mandible during mouth opening will be ranked as straight, right, or left. This observation can be made during the first measurement of mandibular opening
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Occlusal disturbance reported by the patient
The patient will be asked to describe how his/her teeth touch as referring to his/her previous occlusion. He/she will rank his/her occlusion as:
- not modified
- slightly modified as compared to before the trauma but with no significant disturbance
- significantly disturbed
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Occlusal disturbance evaluated by the surgeon
The surgeon will ask the patient to bite and describe the occlusion as:
- Not modified
- Open bite: barely detectable (right / anterior / left) or clearly detectable (right / anterior / left)
- Premature contact: barely detectable (right / anterior / left) or clearly detectable (right / anterior / left)
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Evaluation of pain using a visual analog scale
The patient will be asked to rate his/her maximum pain in the last 2 days on a visual analog scale, 0 representing no pain and 10 representing the worst pain imaginable.
For bilateral fractures, the pain will be assessed separately on each side.
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Subjective functional impairment evaluated by the patient using the Mandibular Function Impairment Questionnaire (MFIQ)
The Mandibular Function Impairment Questionnaire (MFIQ) consisting in 17 items, rated between 0 and 4, which describes the difficulty in several common movement/activities involving the mandible (see questionnaire 1).
Measured: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Duration of sick leave
Measured: From treatment until 12 months
Time to normal activity recovery
Patient will asked on return to work and to normal daily activities (social activities, eating, sports)
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Number of appointments with a physical therapist
The patient will fill in a notebook the number of appointments with a physical therapist since last patient report.
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Number of self-training sessions
The patient will fill in a notebook the number of the number of self-training sessions since last patient report
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Duration of permanent MMF
The patient will fill in a notebook the number of permanent MMF since last patient report
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Duration of transient MMF
The duration of permanent MMF the duration of transient MMF since last patient report
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Duration of application of mobilization elastic band
The patient will fill in a notebook the duration of application of mobilization elastic band.
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Average and Maximal pain
The patient will fill in a notebook the average and maximal pain rate since last patient report
Measured: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start3 May 2023
- Primary completionAug 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-articular Fracture of the Mandibular CondyleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas SCHOUMAN, MD, Principal investigator, AP-HP - Hôpital Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776473
- Sponsor's protocol ID
- APHP180606
- Other IDs
- 2019-A00252-55
- Acronym
- FIAC
- Status last verified
- May 2023
- First submitted
- 17 Feb 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04776473
- Acronym / sponsor ID
- FIAC / APHP180606
- Keywords
- intra-articular fracture, mandibular condyle, surgical treatment, conservative treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Mar 2021 (actual)
- 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.
Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. During the last 15 years, a growing interest has emerged for open (surgical) treatment of these fractures. Although there is more and more evidence suggesting that the open treatment may be the treatment of choice for selected cases of subcondylar fractures, the best option remains controversial for high condylar fractures.
The primary objective of the trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.
This study is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.
Detailed description
The mandibular condyle is one of the most frequent locations of facial fractures. It can lead to severe functional impairment if the occlusion is not properly restored and the mandibular mobility not recovered totally or within an acceptable range. Most frequent sequels of these fractures include limitation of mandibular movements resulting in limited mouth opening, occlusal disturbance causing chewing malfunction, chronic pain, chronic temporo-mandibular joint (TMJ) disorder and facial asymmetry. The risk of permanent limited mouth opening is even higher when the fracture is located inside the TMJ. Although the superiority of surgical treatment is now widely accepted for low-level fractures of the condylar unit (i.e., extra-articular fractures) the treatment of fractures involving the TMJ in adult patients is still controversial.
Treatment principles in these fractures can be ranked in two groups: closed and open treatments. Closed treatment - also called closed reduction or conservative treatment - consists in prolonged physical therapy frequently associated with transient maxillo-mandibular fixation (MMF). Open treatment consists in open reduction and internal fixation of the fracture (ORIF).
No randomized controlled trial has ever evaluated the superiority of open versus closed treatment, and treatment strategy for IAFC remains a matter of ongoing debate.
The primary objective of this trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.
The secondary objectives are to compare between open (surgical) and closed (conservative) treatments:
At 3 weeks, 6 weeks, 3 months, 6 months, and 12 months post-treatment:
- maximal mouth opening (in mm)
- maximal mandibular protrusion (in mm),
- maximal lateral excursion (in mm),
- lateral deviation of the mandible during mouth opening
- occlusal disturbance evaluated by both the patient and the surgeon
- pain using a visual analog scale
- subjective functional impairment as assessed by the Mandibular Function Impairment Questionnaire
Overall:
- duration of sick leave
- time to normal activity recovery (social activities, eating, sports) We will also evaluate compliance with the intervention. This trial is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open (i.e. surgical) treatment | Experimental | Procedure: Open treatmentThis includes reduction and internal fixation of the fracture (ORIF) performed using the preferred surgical approach and bone implants of the including centre that could be associated with one or several items among the following: * physical therapy based on exercises done by the patient himself * physical therapy performed by a specialized/non-specialized physical therapist * arch bars / screws / splint use for transient MMF * arch bars / screws / splint use for passive mobilization of the mandible |
| Closed (i.e. conservative) treatment | Other | Other: Closed treatmentTo date, there is no consensus on which procedures should be used in case of conservative treatment, which may vary between centres and, for a same centre, between patients. This includes one or several items among the following: * physical therapy based on exercises done by the patient himself * physical therapy performed by a specialized/non-specialized physical therapist * arch bars / screws / splint use for transient maxillo-mandibular fixation (MMF) (15 days max) * arch bars / screws / splint use for passive mobilization of the mandible |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (≥18 y-o) < 85 years
- Displaced non-comminuted intra-articular fracture of the mandibular condyle (IAFC) as defined by a fracture line above a horizontal line tangent to the mandibular notch
- Objectifiable induced malocclusion and/or ramus shortening ≥2 mm on CT-scan (a ramus shortening ≥2 mm on CT-scan is necessary in case of other associated mandibular or occluso-facial fractures)
- Unilateral or bilateral fracture
- Isolated or associated with other facial / extra-facial skeleton / dental / soft tissue lesions
Key exclusion criteria (8 listed)
- Contraindication to surgical treatment (for any medical or anatomical reason, like comminuted fracture for instance)
- Major teeth loss or edentulous patient (occlusion impossible to assess)
- History of mandibular fracture
- History of temporo-mandibular joint (TMJ) disorder
- Dentofacial dysmorphosis causing significant malocclusion
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 |
|---|---|---|
| Open treatmentAlso: Surgical treatmentOpen (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach. | Procedure or surgery | Open (i.e. surgical) treatment |
| Closed treatmentAlso: Conservative treatmentClosed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach. | Other | Closed (i.e. conservative) treatment |
Primary outcome
Maximal mouth opening (in mm) at 3 months
Time frame: 3 months (+/-10 days)
It will be obtained by measuring the interincisal distance at maximum mouth opening with a caliper or a ruler. The patient will be first asked to open the mouth as widely as possible for 3 seconds and to rest for 5 seconds. This sequence will be repeated 2 times and at the third repetition the patient will keep his/her mouth opened while the physician will measure inter-incisal distance
16 secondary outcomes
Maximal mouth opening (in mm)
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Maximal mandibular protrusion (in mm)
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Maximal lateral excursion (in mm)
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Lateral deviation of the mandible during mouth opening
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Occlusal disturbance reported by the patient
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Occlusal disturbance evaluated by the surgeon
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Evaluation of pain using a visual analog scale
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Subjective functional impairment evaluated by the patient using the Mandibular Function Impairment Questionnaire (MFIQ)
Time frame: 3 weeks (+/- 7 days), 6 weeks (+/-7 days), 3 months (+/-10 days), 6 months (+/-20 days) and, 12 months (+/- 30 days) post-treatment
Duration of sick leave
Time frame: From treatment until 12 months
Time to normal activity recovery
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Number of appointments with a physical therapist
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Number of self-training sessions
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Duration of permanent MMF
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Duration of transient MMF
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Duration of application of mobilization elastic band
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Compliance with the intervention - Average and Maximal pain
Time frame: Every week from week 1 to 6, every 2 weeks from week 8 to 12, and every month from month 4 to 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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.
Thomas SCHOUMAN, MD principal investigator
AP-HP - Hôpital Pitié-Salpêtrière
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open treatment and Closed treatment in people with Intra-articular Fracture of the Mandibular Condyle, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas SCHOUMAN, MD ((0)1 42 16 13 01 ext. +33, thomas.schouman@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal mouth opening (in mm) at 3 months (time frame: 3 months (+/-10 days)). 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 16 May 2023.