Recurrent Dislocation of Temporomandibular Joint (Disorder)NCT05377593
Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation
A study testing eminoplasty with patient specific Zirconium dioxide onlay implant in people with Recurrent Dislocation of Temporomandibular Joint (Disorder), run by Cairo University at 1 site in Egypt.
Trial summary
Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Dislocation of Temporomandibular Joint (Disorder)
- What is being tested?
- eminoplasty with patient specific Zirconium dioxide onlay implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2022to 1 Jun 2024
- 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 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with recurrent dislocation with maximum inter incisal opening over 55mm
- Long-standing dislocation of the TMJ involving both fixation 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
- Both sexes
- Age between 18 and 48 years.
- Highly motivated patients.
Who cannot join
- Post-menopausal females with osteoporosis
- Patient with uncontrolled systemic disease
- pregnancy
- psychological disorders, drug or alcohol dependency
- Known allergies or sensitivities to dental materials, including Zirconia, Titanium or general anesthetic agents
- Inability to return for follow up visits.
- Refusal of participation from the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial
Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction.
- Being tested
- eminoplasty with patient specific Zirconium dioxide onlay implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eminoplasty with patient specific Zirconium dioxide onlay implantDevice
Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants
| Study group | Role | What they receive |
|---|---|---|
| eminoplasty with patient specific Titanium onlay implant | Active comparator | Not described Receives: Device: eminoplasty with patient specific Zirconium dioxide onlay implant |
| eminoplasty with patient specific zirconium dioxide onlay implant | Active comparator | Not described Receives: Device: eminoplasty with patient specific Zirconium dioxide onlay implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)
using a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)
Measured: 6 months
Secondary outcomes (1)
Patient's Pain
in terms of visual analogue scale (0-10)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start23 Mar 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Dislocation of Temporomandibular Joint (Disorder)Studies 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
- Model description
- A Randomized Clinical Trial A Trial will be carried out in hospital of Oral and Maxillofacial Surgery department- Faculty of dentistry Cairo University. Equal Randomization: Participants receiving treatment. Positive Controlled: Both groups receiving treatment. Parallel group study: each group of patients receives single treatment simultaneously.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Zakaria, Cairo University
- Investigators
- Mohammed Kadry Nasr, Doctorate, Study director, Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377593
- Sponsor's protocol ID
- OMFS 3-3-4
- Status last verified
- Jun 2024
- First submitted
- 10 May 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05377593
- Acronym / sponsor ID
- OMFS 3-3-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 17 May 2022 (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.
Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized Clinical Trial A Trial will be carried out in hospital of Oral and Maxillofacial Surgery department- Faculty of dentistry Cairo University. Equal Randomization: Participants receiving treatment. Positive Controlled: Both groups receiving treatment. Parallel group study: each group of patients receives single treatment simultaneously.
| Arm | Type | Receives |
|---|---|---|
| eminoplasty with patient specific Titanium onlay implant | Active comparator | Device: eminoplasty with patient specific Zirconium dioxide onlay implant |
| eminoplasty with patient specific zirconium dioxide onlay implant | Active comparator | Device: eminoplasty with patient specific Zirconium dioxide onlay implant |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with recurrent dislocation with maximum inter incisal opening over 55mm
- Long-standing dislocation of the TMJ involving both fixation 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
- Both sexes
- Age between 18 and 48 years.
Key exclusion criteria (7 listed)
- Post-menopausal females with osteoporosis
- Patient with uncontrolled systemic disease
- pregnancy
- psychological disorders, drug or alcohol dependency
- Known allergies or sensitivities to dental materials, including Zirconia, Titanium or general anesthetic agents
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 |
|---|---|---|
| eminoplasty with patient specific Zirconium dioxide onlay implantEminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants | Device | eminoplasty with patient specific Titanium onlay implant, eminoplasty with patient specific zirconium dioxide onlay implant |
Primary outcome
Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)
Time frame: 6 months
using a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)
1 secondary outcome
Patient's Pain
Time frame: 6 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 4 Jun 2024.
- 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.
Mohammed Kadry Nasr, Doctorate study director
Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eminoplasty with patient specific Zirconium dioxide onlay implant in people with Recurrent Dislocation of Temporomandibular Joint (Disorder), run by Cairo University 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 6 inclusion and 7 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 4 Jun 2024. 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?
Difference in Maximal inter incisal distance between pre-operative and post-operative (mm) (time frame: 6 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 4 Jun 2024.