TMJNCT06936072
Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique
A study testing Titanium Ring Inlay Eminence Augmentation in people with TMJ and Augmentation, run by Sinai University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation Read more about this study
- Who is it for?
- Ages 25 to 41 years
- Conditions the study is for
- TMJ, Augmentation, TMJ - Oral &Amp;Maxillofacial Surgery
- What is being tested?
- Titanium Ring Inlay Eminence Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Apr 2024to 3 Apr 2025
- 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 25 to 41 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed TMJ dysfunction requiring eminence augmentation
- Failed conservative management (≥3 months)
- Adequate bone stock for inlay placement
- Willingness to comply with follow-up protocol
Who cannot join
- Systemic conditions contraindicating surgery
- Active TMJ infection
- Previous TMJ surgery
- Pregnancy
- Neuromuscular disorders-
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia University, Faculty of Medicine, University Hospital
Menoufia University
About this study
To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation
Read the detailed description
Background:Temporomandibular joint (TMJ) disorders affect approximately 5-12% of the population, with eminence augmentation being a challenging surgical intervention. Current techniques using autogenous grafts or alloplastic materials present limitations including donor site morbidity, resorption, and implant failure. This study evaluates a novel titanium ring inlay technique for TMJ eminence augmentation, which may offer improved stability, osseointegration, and functional outcomes.
Patients and Methods: A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024; . Titanium ring inlay procedure was performed to Temporomandibular joint eminence augmentation. Preoperative and postoperative assessments included pain levels (VAS pain), maximum mouth opening (MMO), Clicking during mouth opening, Headach presence, tinnitus and subjective patient feedback.
- Conditions
- TMJ, Augmentation, TMJ - Oral &Amp;Maxillofacial Surgery
- Being tested
- Titanium Ring Inlay Eminence Augmentation
- Keywords
- TMJ, TMJ augmentation, Augmentation, Oral and Maxillofacial surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium Ring Inlay Eminence AugmentationProcedure or surgery
- Preauricular approach with subperiosteal dissection
- Dual osteotomy (transverse mid-eminence + vertical parallel to skull base)
- Titanium ring inlay placement with anatomical contouring
- Intraoperative functional assessment
| Study group | Role | What they receive |
|---|---|---|
| Titanium Ring Inlay Eminence Augmentation Group | Experimental | Procedure:
Novel titanium ring inlay eminence augmentation via modified ESS technique
Inverted L-shaped osteotomy with controlled greenstick fracture
Precise titanium ring (12-15mm diameter) implantation
Surgical Protocol:
* Preauricular approach with subperiosteal dissection
* Dual osteotomy (transverse mid-eminence + vertical parallel to skull base)
* Titanium ring inlay placement with anatomical contouring
* Intraoperative functional assessment
Postoperative Care:
* Standardized analgesic protocol
* Physiotherapy protocol initiation at 2 weeks
* Gradual return to function protocol
Follow-up Schedule:
* Clinical assessments at 5 timepoints (T0-T4)
* Standardized outcome measurements (VAS, MIO, etc.)
Key Characteristics:
Single-arm interventional design
All participants receive identical surgical protocol
Standardized outcome assessment methodology
Blinded evaluators for outcome measures (where applicable)
Rationale for Single Arm Design:
First-in-human evaluation of nov Receives: Procedure: Titanium Ring Inlay Eminence Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional improvement
Measuring the Maximal interincisal opening (MIO; mm)
Measured: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Secondary outcomes (3)
Pain Score
Measuring the Visual Analogue Scale (VAS), pain score (1-10)
Measured: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Headache
Measuring the Headache Assessment Presence Yes/No
Measured: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Tinnitus
Tinnitus presence (Y/N)
Measured: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start28 Apr 2024
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJStudies 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
- Model description
- A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Mohamed Moawed Ibrahim Ghoneim, PhD, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936072
- Sponsor's protocol ID
- OMS 1-04-024
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Joint Eminence Augmentation Using Titanium Ring Inlay: A New Surgical Technique
- ClinicalTrials.gov ID
- NCT06936072
- Acronym / sponsor ID
- OMS 1-04-024
- Conditions
- TMJ, Augmentation, TMJ - Oral &Amp;Maxillofacial Surgery
- Keywords
- TMJ, TMJ augmentation, Augmentation, Oral and Maxillofacial surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 20 Apr 2025 (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.
To evaluate the efficacy of titanium ring inlay in ESS technique in Temporomandibular joint eminence augmentation
Detailed description
Background:Temporomandibular joint (TMJ) disorders affect approximately 5-12% of the population, with eminence augmentation being a challenging surgical intervention. Current techniques using autogenous grafts or alloplastic materials present limitations including donor site morbidity, resorption, and implant failure. This study evaluates a novel titanium ring inlay technique for TMJ eminence augmentation, which may offer improved stability, osseointegration, and functional outcomes.
Patients and Methods: A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024; . Titanium ring inlay procedure was performed to Temporomandibular joint eminence augmentation. Preoperative and postoperative assessments included pain levels (VAS pain), maximum mouth opening (MMO), Clicking during mouth opening, Headach presence, tinnitus and subjective patient feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee, Faculty of Dentistry, Sinai University OMS 01-04-024.
| Arm | Type | Receives |
|---|---|---|
| Titanium Ring Inlay Eminence Augmentation Group | Experimental | Procedure: Titanium Ring Inlay Eminence AugmentationProcedure: Novel titanium ring inlay eminence augmentation via modified ESS technique Inverted L-shaped osteotomy with controlled greenstick fracture Precise titanium ring (12-15mm diameter) implantation Surgical Protocol: * Preauricular approach with subperiosteal dissection * Dual osteotomy (transverse mid-eminence + vertical parallel to skull base) * Titanium ring inlay placement with anatomical contouring * Intraoperative functional assessment Postoperative Care: * Standardized analgesic protocol * Physiotherapy protocol initiation at 2 weeks * Gradual return to function protocol Follow-up Schedule: * Clinical assessments at 5 timepoints (T0-T4) * Standardized outcome measurements (VAS, MIO, etc.) Key Characteristics: Single-arm interventional design All participants receive identical surgical protocol Standardized outcome assessment methodology Blinded evaluators for outcome measures (where applicable) Rationale for Single Arm Design: First-in-human evaluation of nov |
Who may qualify
- Ages
- 25 to 41 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed TMJ dysfunction requiring eminence augmentation
- Failed conservative management (≥3 months)
- Adequate bone stock for inlay placement
- Willingness to comply with follow-up protocol
Key exclusion criteria (5 listed)
- Systemic conditions contraindicating surgery
- Active TMJ infection
- Previous TMJ surgery
- Pregnancy
- Neuromuscular disorders-
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 |
|---|---|---|
| Titanium Ring Inlay Eminence Augmentation* Preauricular approach with subperiosteal dissection * Dual osteotomy (transverse mid-eminence + vertical parallel to skull base) * Titanium ring inlay placement with anatomical contouring * Intraoperative functional assessment | Procedure or surgery | Titanium Ring Inlay Eminence Augmentation Group |
Primary outcome
Functional improvement
Time frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Measuring the Maximal interincisal opening (MIO; mm)
3 secondary outcomes
Pain Score
Time frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Headache
Time frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
Tinnitus
Time frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).
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 20 Apr 2025.
- Individual participant dataSharing planned: Undecided. A prospective study was conducted on 100 patients (28 males, 72 females; age range: 25-41 years) with TMJ Temporomandibular joint eminence augmentation. Study was performed after ethical approval from Research Ethics Committee.
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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.
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 Titanium Ring Inlay Eminence Augmentation in people with TMJ and Augmentation, run by Sinai 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 4 inclusion and 5 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 20 Apr 2025. 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?
Functional improvement (time frame: Baseline (T0); T1 (1 months postoperative); T2 (3 months postoperative); T3 (6 months postoperative); T4 (12 months postoperative).). 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 20 Apr 2025.