Chronic Mandibular Condylar DislocationNCT03728270
Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation
A study testing Patient Specific Titanium Eminoplasty and Inlay Autogenous Bone Graft in people with Chronic Mandibular Condylar Dislocation, run by Cairo University.
Trial summary
In the small and highly specialized field of TMJ surgical treatments, restriction of the mandibular condylar movement outside of the articular eminence is one of the treatment choices suggested in TMJ dislocation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Mandibular Condylar Dislocation
- What is being tested?
- Patient Specific Titanium Eminoplasty and Inlay Autogenous Bone Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Feb 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients.
- Long-standing dislocation of the TMJ for more than 3 weeks and the failure of manual reduction.
- Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage.
- Previous failed TMJ surgery.
- Age range is between 18 and 40 years with no sex predilection.
- Patients who can understand Visual Analogue Scales (VAS) and are able to sign informed consent
- Highly motivated patients
Who cannot join
- Pregnant females.
- Patients having a significant systemic disorder.
- Psychological disorders, drug or alcohol dependency.
- Known allergies or sensitivities to dental materials, including Titanium or general anasethic agents.
- Severe medical conditions that would not allow management in the clinic.
- Inability to return for follow up visits.
About this study
In the small and highly specialized field of TMJ surgical treatments, restriction of the mandibular condylar movement outside of the articular eminence is one of the treatment choices suggested in TMJ dislocation.
Limitation of translation of the condyle in TMJ dislocation by inlay autogenous bone graft is the classic method to hinder the movement of the condyle beyond the articular eminence.
Read more
Patient specific TMJ prosthesis is very promising nowadays that it will not only build on the strengths of the current TMJ systems but will take advantage of digital innovations in custom design and three-dimensional(3D) printing of TMJ prosthesis. Moreover, TMJ Titanium eminoloplasty was reported to be a predictable and flexible instrument for TMJ dislocation treatment.
Thus, the investigators are conducting this study to compare the effect of both methods on the improvement of the maximal incisal opening of patients with chronic mandibular condylar dislocation, aiming to solve the problem of increasing the mouth opening of patients in their daily mouth opening. Also to reduce the community's fear from such a problem, which sometimes prevent patients from seeking treatment at their dentists leading to more serious complications that can be avoided. Furthermore, the investigators are trying to provide an evidence for oral and maxillofacial surgeons in order to provide the best quality service with the least expenses and thus gaining the patients' trust and saving time, money and effort.
- Conditions
- Chronic Mandibular Condylar Dislocation
- Being tested
- Patient Specific Titanium Eminoplasty, Inlay Autogenous Bone Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific Titanium EminoplastyDevice
- The stages of virtual surgical planning and fabrication of patient specific titanium eminoplasty will be designed my Mimics 15 program.
- Once designed, the virtual design and surgery will be planned on a computer model where vital anatomical structures could be identified and thus could be avoided during surgery.
- After obtaining all the dataset needed from the CT scan, the collected data will be sent to the Egyptian soil, water and environmental institution for manufacturing, packing and sterilization of the patient specific titanium eminence.
- The patient specific titanium eminence will be inserted and secured with two to three screws of individual lengths according to the virtual plan.
- Functional mandibular movements were reproduced to confirm absence of subluxation and checked for interference and any required adjustments made.
- A multilayer closure of the incisions will be accomplished using Vicryl
Inlay Autogenous Bone GraftProcedure or surgery
- Steps to harvest the bone graft:
- Down-fracture of the articular eminence to be augmented with Inlay bone graft to increase the vertical height of the articular eminence. A green-stick fracture will be created avoiding a possible complete fracture of the lower segment of the eminence
- To obtain Inlay bone graft from the chin, anterior mandibular vestibule incision will provide good access to the mandibular symphysis.
| Study group | Role | What they receive |
|---|---|---|
| Patient Specific Titanium Eminoplasty | Experimental | * The stages of virtual surgical planning and fabrication of patient specific titanium eminoplasty will be designed my Mimics 15 program.
* Once designed, the virtual design and surgery will be planned on a computer model where vital anatomical structures could be identified and thus could be avoided during surgery.
* After obtaining all the dataset needed from the CT scan, the collected data will be sent to the Egyptian soil, water and environmental institution for manufacturing, packing and sterilization of the patient specific titanium eminence.
* The patient specific titanium eminence will be inserted and secured with two to three screws of individual lengths according to the virtual plan.
* Functional mandibular movements were reproduced to confirm absence of subluxation and checked for interference and any required adjustments made.
* A multilayer closure of the incisions will be accomplished using Vicryl sutures. Receives: Device: Patient Specific Titanium Eminoplasty |
| Inlay Autogenous Bone Graft | Active comparator | * A safety distance of 5 mm will be maintained from the apex of the mandibular incisor and inferior mandibular border, the mental foramen, and permanent canine follicle.
* One corticocancellous bone block with a maximum depth of 4 mm will be removed by mallet and chisel based on the recommendation that bone from the chin should be harvested at this maximum depth, compatible with the course of the mandibular incisive nerve canal on CT scans.
* After removal of bone from the chin, the intervening bone struts will be removed using rongeur forceps and used as an additional bone graft.
* The bone removed will be trimmed and contoured in a wedge form to be used as an inter-positional graft in the previously down fractured articular eminence to act as an obstacle in front of the mandibular condyle to prevent its hyper movement. Receives: Procedure: Inlay Autogenous Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximal incisal opening
will be measured using a caliper.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mandibular Condylar DislocationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ihab Younis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728270
- Sponsor's protocol ID
- 33377576
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maximal Incisal Opening Using Patient Specific Titanium Eminoplasty Versus Inlay Autogenous Bone Graft for Treatment of Chronic Mandibular Condylar Dislocation
- ClinicalTrials.gov ID
- NCT03728270
- Acronym / sponsor ID
- 33377576
- Conditions
- Chronic Mandibular Condylar Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 2 Nov 2018 (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.
In the small and highly specialized field of TMJ surgical treatments, restriction of the mandibular condylar movement outside of the articular eminence is one of the treatment choices suggested in TMJ dislocation.
Limitation of translation of the condyle in TMJ dislocation by inlay autogenous bone graft is the classic method to hinder the movement of the condyle beyond the articular eminence.
Patient specific TMJ prosthesis is very promising nowadays that it will not only build on the strengths of the current TMJ systems but will take advantage of digital innovations in custom design and three-dimensional(3D) printing of TMJ prosthesis. Moreover, TMJ Titanium eminoloplasty was reported to be a predictable and flexible instrument for TMJ dislocation treatment.
Thus, the investigators are conducting this study to compare the effect of both methods on the improvement of the maximal incisal opening of patients with chronic mandibular condylar dislocation, aiming to solve the problem of increasing the mouth opening of patients in their daily mouth opening. Also to reduce the community's fear from such a problem, which sometimes prevent patients from seeking treatment at their dentists leading to more serious complications that can be avoided. Furthermore, the investigators are trying to provide an evidence for oral and maxillofacial surgeons in order to provide the best quality service with the least expenses and thus gaining the patients' trust and saving time, money and effort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Specific Titanium Eminoplasty | Experimental | Device: Patient Specific Titanium Eminoplasty* The stages of virtual surgical planning and fabrication of patient specific titanium eminoplasty will be designed my Mimics 15 program. * Once designed, the virtual design and surgery will be planned on a computer model where vital anatomical structures could be identified and thus could be avoided during surgery. * After obtaining all the dataset needed from the CT scan, the collected data will be sent to the Egyptian soil, water and environmental institution for manufacturing, packing and sterilization of the patient specific titanium eminence. * The patient specific titanium eminence will be inserted and secured with two to three screws of individual lengths according to the virtual plan. * Functional mandibular movements were reproduced to confirm absence of subluxation and checked for interference and any required adjustments made. * A multilayer closure of the incisions will be accomplished using Vicryl sutures. |
| Inlay Autogenous Bone Graft | Active comparator | Procedure: Inlay Autogenous Bone Graft* A safety distance of 5 mm will be maintained from the apex of the mandibular incisor and inferior mandibular border, the mental foramen, and permanent canine follicle. * One corticocancellous bone block with a maximum depth of 4 mm will be removed by mallet and chisel based on the recommendation that bone from the chin should be harvested at this maximum depth, compatible with the course of the mandibular incisive nerve canal on CT scans. * After removal of bone from the chin, the intervening bone struts will be removed using rongeur forceps and used as an additional bone graft. * The bone removed will be trimmed and contoured in a wedge form to be used as an inter-positional graft in the previously down fractured articular eminence to act as an obstacle in front of the mandibular condyle to prevent its hyper movement. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medically free patients.
- Long-standing dislocation of the TMJ for more than 3 weeks and the failure of manual reduction.
- Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage.
- Previous failed TMJ surgery.
- Age range is between 18 and 40 years with no sex predilection.
Key exclusion criteria (6 listed)
- Pregnant females.
- Patients having a significant systemic disorder.
- Psychological disorders, drug or alcohol dependency.
- Known allergies or sensitivities to dental materials, including Titanium or general anasethic agents.
- Severe medical conditions that would not allow management in the clinic.
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 |
|---|---|---|
| Patient Specific Titanium Eminoplasty* The stages of virtual surgical planning and fabrication of patient specific titanium eminoplasty will be designed my Mimics 15 program. * Once designed, the virtual design and surgery will be planned on a computer model where vital anatomical structures could be identified and thus could be avoided during surgery. * After obtaining all the dataset needed from the CT scan, the collected data will be sent to the Egyptian soil, water and environmental institution for manufacturing, packing and sterilization of the patient specific titanium eminence. * The patient specific titanium eminence will be inserted and secured with two to three screws of individual lengths according to the virtual plan. * Functional mandibular movements were reproduced to confirm absence of subluxation and checked for interference and any required adjustments made. * A multilayer closure of the incisions will be accomplished using Vicryl | Device | Patient Specific Titanium Eminoplasty |
| Inlay Autogenous Bone Graft* Steps to harvest the bone graft: * Down-fracture of the articular eminence to be augmented with Inlay bone graft to increase the vertical height of the articular eminence. A green-stick fracture will be created avoiding a possible complete fracture of the lower segment of the eminence * To obtain Inlay bone graft from the chin, anterior mandibular vestibule incision will provide good access to the mandibular symphysis. | Procedure or surgery | Inlay Autogenous Bone Graft |
Primary outcome
The maximal incisal opening
Time frame: 9 months
will be measured using a caliper.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Specific Titanium Eminoplasty and Inlay Autogenous Bone Graft in people with Chronic Mandibular Condylar Dislocation, run by Cairo University.
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 7 inclusion and 6 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 2 Nov 2018. 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?
Results are not available in the source record.
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 maximal incisal opening (time frame: 9 months). 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 2 Nov 2018.