Bilateral or Unilateral Deficient Ramus-condyle UnitNCT04383964
Transport Distraction Osteogenesis for Ramus-Condyle Unit
A study testing Distraction Osteogenesis for Reconstruction of Ramus-Condyle in people with Bilateral or Unilateral Deficient Ramus-condyle Unit, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
this study was done to evaluate the use of transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to correct the resultant deformity Read more about this study
- Who is it for?
- Ages 1 year to 50 years
- Conditions the study is for
- Bilateral or Unilateral Deficient Ramus-condyle Unit
- What is being tested?
- Distraction Osteogenesis for Reconstruction of Ramus-Condyle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 15 Jul 2019
- 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 1 year to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Post ankylosis deformity: Bilateral or unilateral deficient ramus-condyle unit (RCU) after TMJ release
Who cannot join
- Mentally affected patients.
- Medically compromised patients.
- Post menopausal osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transport Distraction Osteogenesis for Reconstruction of Ramus-Condyle Unit Following Release of Temporomandibular Joint Ankylosis
this study was done to evaluate the use of transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to correct the resultant deformity
Read the detailed description
10 patients with post ankylosis deficient ramus /condyle unit who underwent release procedure in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt.
all patients were assessed clinically and by imaging using OPG, lateral and PA cephalometry, and cone beam CT to assess the deficient ramus/condyle unit (RCU) then patients were operated using transport distraction osteogenesis to lengthen the RCU. Then follow up of all patients both clinically and radiographically was adopted.
- Being tested
- Distraction Osteogenesis for Reconstruction of Ramus-Condyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction Osteogenesis for Reconstruction of Ramus-CondyleDevice
transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Transport distraction osteogenesis | Experimental | Locally made and designed submerged monodirectional in the vertical (Y) axis distractor was used.
A transport disc is created at the remaining stump of the RCU with an L shaped osteotomy.
The prepared disc is to be wide enough to fit the upper portion of the distrcator.
The submerged distractor will be placed in a position to guide the transport disc moving up and backwards toward the glenoid fossa.
The length of the distractor is determined according to the amount of distraction planned to reach the glenoid fossa. Receives: Device: Distraction Osteogenesis for Reconstruction of Ramus-Condyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw movements (changes in jaw movements through 18 months follow up)
Mouth opening in mm, Jaw movement in lateral excursion and opening.
Measured: at 3rd, 6th and 18th months
Ramus height (changes of ramus heights through 18 months follow up)
Determination of the height of the ramus by PA cephalometric, Lateral cephalometric x-rays and tracings
Measured: at 3rd and 6th months
Secondary outcomes (1)
Occlusal discrepancy or anterior open bite
Occlusal discrepancy or anterior open bite
Measured: 18th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jan 2018
- Primary completion27 Apr 2018
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral or Unilateral Deficient Ramus-condyle UnitStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383964
- Sponsor's protocol ID
- Distraction Osteogenesis
- Status last verified
- Jul 2020
- First submitted
- 6 May 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transport Distraction Osteogenesis for Reconstruction of Ramus-Condyle Unit Following Release of Temporomandibular Joint Ankylosis
- ClinicalTrials.gov ID
- NCT04383964
- Acronym / sponsor ID
- Distraction Osteogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 12 May 2020 (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.
this study was done to evaluate the use of transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to correct the resultant deformity
Detailed description
10 patients with post ankylosis deficient ramus /condyle unit who underwent release procedure in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt.
all patients were assessed clinically and by imaging using OPG, lateral and PA cephalometry, and cone beam CT to assess the deficient ramus/condyle unit (RCU) then patients were operated using transport distraction osteogenesis to lengthen the RCU. Then follow up of all patients both clinically and radiographically was adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transport distraction osteogenesis | Experimental | Device: Distraction Osteogenesis for Reconstruction of Ramus-CondyleLocally made and designed submerged monodirectional in the vertical (Y) axis distractor was used. A transport disc is created at the remaining stump of the RCU with an L shaped osteotomy. The prepared disc is to be wide enough to fit the upper portion of the distrcator. The submerged distractor will be placed in a position to guide the transport disc moving up and backwards toward the glenoid fossa. The length of the distractor is determined according to the amount of distraction planned to reach the glenoid fossa. |
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Post ankylosis deformity: Bilateral or unilateral deficient ramus-condyle unit (RCU) after TMJ release
Key exclusion criteria (3 listed)
- Mentally affected patients.
- Medically compromised patients.
- Post menopausal osteoporosis.
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 |
|---|---|---|
| Distraction Osteogenesis for Reconstruction of Ramus-Condyletransport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally. | Device | Transport distraction osteogenesis |
Primary outcome
Jaw movements (changes in jaw movements through 18 months follow up)
Time frame: at 3rd, 6th and 18th months
Mouth opening in mm, Jaw movement in lateral excursion and opening.
Ramus height (changes of ramus heights through 18 months follow up)
Time frame: at 3rd and 6th months
Determination of the height of the ramus by PA cephalometric, Lateral cephalometric x-rays and tracings
1 secondary outcome
Occlusal discrepancy or anterior open bite
Time frame: 18th months
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 23 Jul 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction Osteogenesis for Reconstruction of Ramus-Condyle in people with Bilateral or Unilateral Deficient Ramus-condyle Unit, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 23 Jul 2020. 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 Egypt. 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?
Jaw movements (changes in jaw movements through 18 months follow up) (time frame: at 3rd, 6th and 18th months). The study lists 2 primary outcomes in all. 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 23 Jul 2020.