Temporomandibular Joint DisordersNCT06132594
Computed Guided Prolotherapy Versus Conventional Prolotherapy
A study testing Conventional arthrocentesis followed by I-PRF injection and 3d surgical guided Arthrocentesis followed by I-PRF injection in people with Temporomandibular Joint Disorders and Orofacial Pain, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Orofacial Pain
- What is being tested?
- Conventional arthrocentesis followed by I-PRF injection and 3d surgical guided Arthrocentesis followed by I-PRF injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2021to 14 Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral or unilateral TMJ internal derangement.
- No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
- Ability to undergo MRI or CT scans without contraindications.
Who cannot join
- Those with systemic diseases (polyarthritis or rheumatoid diseases).
- Individuals with neurologic disorders.
- Patients with a history of condylar fracture or previous TMJ injections.
- Those with head and neck cancer.
- Completely edentulous patients (lacking teeth).
- Individuals with implanted metal or medical devices.
- Patients with developmental and congenital disorders of the TMJ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment
The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.
Read the detailed description
This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).
Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.
Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.
Preparation of I-PRF:
The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.
- Conditions
- Temporomandibular Joint Disorders, Orofacial Pain
- Being tested
- Conventional arthrocentesis followed by I-PRF injection, 3d surgical guided Arthrocentesis followed by I-PRF injection
- Keywords
- TMD, Temporomandibular Joint Disorders, Prolotherapy of TMJ, Guided Arthrocentesis
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional arthrocentesis followed by I-PRF injectionProcedure or surgery
An auriculotemporal nerve block using Mebacaine 0.5% was administered near the mandible's neck. The patient sat at a 45° angle with their head turned. The posterior entry point was 10 mm from the midtragus and 2 mm below the line, while the anterior entry point was marked 20 mm from the midtragus and 10 mm below the line. A biting block kept the mouth open. 2-3 ml of Ringer lactate was injected with an 18-gauge needle to enlarge the joint space. A second needle allowed the solution to flow freely. After lavaging the joint, 1 ml of I-PRF was injected into the upper joint space. Jaw manipulation was done to address adhesions and improve disc mobility.
3d surgical guided Arthrocentesis followed by I-PRF injectionProcedure or surgery
Patients underwent arthrocentesis with Ringer lactate, followed by I-PRF injection in the TMJ's superior space using a CT-planned 3D-printed guide. Positioned at a 45° angle, patients were comfortably seated, and disinfection was performed. The patient-specific guide, fitting over maxillary teeth and the face, was employed unilaterally or bilaterally with a biting block for mouth opening maintenance. An 18-gauge needle administered 2-3 ml of Ringer lactate, widening the joint space, followed by a second needle allowing free solution flow (80-90 ml) to flush the superior joint space. Post-arthrocentesis, 1 ml of I-PRF was injected. To enhance joint mobility and free the disc, gentle manipulation of the lower jaw was performed after removing the needles and guide.
| Study group | Role | What they receive |
|---|---|---|
| Group I; Conventional arthrocentesis followed by I-PRF injection | Experimental | Patients received arthrocentesis followed by I-PRF injection, employing the conventional TMJ injection technique aided by facial anatomical landmarks Receives: Procedure: Conventional arthrocentesis followed by I-PRF injection |
| Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection | Experimental | Patients received arthrocentesis followed by I-PRF injection with the assistance of a CT-guided 3D printed surgical guide. Receives: Procedure: 3d surgical guided Arthrocentesis followed by I-PRF injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain
Using visual analog scale
Measured: Intraoperative,1 week, 1month and 3 months
The number of needle insertion attempts
The number of needle insertions, indicative of the attempts, was counted for each group.
Measured: Intraoperative
Secondary outcomes (2)
Maximal incisal opening
Using digital caliper in Millimeter (mm)
Measured: 1 week, 1month and 3 months
Time of operation
In minutes
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start2 Oct 2021
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahran Arafat Ahmed Arafat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132594
- Sponsor's protocol ID
- AUAREC20210100-09
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998.
PubMed 26929478Laskin DM. Arthroscopy Versus Arthrocentesis for Treating Internal Derangements of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):325-328. doi: 10.1016/j.coms.2018.04.008. Epub 2018 Jun 1.
PubMed 29866452Custodio ALN, Cameron A, Bakr M, Little C, Chrcanovic BR, Reher P. Positioning accuracy assessment of minimally invasive percutaneous injection techniques for the treatment of temporomandibular disorders. Dentomaxillofac Radiol. 2021 Feb 1;50(2):20200313. doi: 10.1259/dmfr.20200313. Epub 2020 Jul 24.
PubMed 32706994Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.
PubMed 27118616Mahmoud K, Galal N, Ali S, Gibaly A, Elbehairy MS, Mounir M. Computer-Guided Arthrocentesis Using Patient-Specific Guides: A Novel Protocol for Treatment of Internal Derangement of the Temporomandibular Joint. J Oral Maxillofac Surg. 2020 Mar;78(3):372.e1-372.e7. doi: 10.1016/j.joms.2019.10.005. Epub 2019 Oct 15.
PubMed 31705867Hyder A, Tawfik BE, Elmohandes W. Efficacy of computer-guided versus conventional sodium hyaluronate injection in superior joint space in treatment of temporomandibular joint (TMJ) internal derangement: Comparative randomized controlled trial. J Stomatol Oral Maxillofac Surg. 2022 Oct;123(5):e321-e326. doi: 10.1016/j.jormas.2022.05.007. Epub 2022 May 8.
PubMed 35545190
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment
- ClinicalTrials.gov ID
- NCT06132594
- Acronym / sponsor ID
- AUAREC20210100-09
- Conditions
- Temporomandibular Joint Disorders, Orofacial Pain
- Keywords
- TMD, Temporomandibular Joint Disorders, Prolotherapy of TMJ, Guided Arthrocentesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 15 Nov 2023 (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.
The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.
Detailed description
This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).
Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.
Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.
Preparation of I-PRF:
The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I; Conventional arthrocentesis followed by I-PRF injection | Experimental | Procedure: Conventional arthrocentesis followed by I-PRF injectionPatients received arthrocentesis followed by I-PRF injection, employing the conventional TMJ injection technique aided by facial anatomical landmarks |
| Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection | Experimental | Procedure: 3d surgical guided Arthrocentesis followed by I-PRF injectionPatients received arthrocentesis followed by I-PRF injection with the assistance of a CT-guided 3D printed surgical guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral or unilateral TMJ internal derangement.
- No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
- Ability to undergo MRI or CT scans without contraindications.
Key exclusion criteria (7 listed)
- Those with systemic diseases (polyarthritis or rheumatoid diseases).
- Individuals with neurologic disorders.
- Patients with a history of condylar fracture or previous TMJ injections.
- Those with head and neck cancer.
- Completely edentulous patients (lacking teeth).
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 |
|---|---|---|
| Conventional arthrocentesis followed by I-PRF injectionAn auriculotemporal nerve block using Mebacaine 0.5% was administered near the mandible's neck. The patient sat at a 45° angle with their head turned. The posterior entry point was 10 mm from the midtragus and 2 mm below the line, while the anterior entry point was marked 20 mm from the midtragus and 10 mm below the line. A biting block kept the mouth open. 2-3 ml of Ringer lactate was injected with an 18-gauge needle to enlarge the joint space. A second needle allowed the solution to flow freely. After lavaging the joint, 1 ml of I-PRF was injected into the upper joint space. Jaw manipulation was done to address adhesions and improve disc mobility. | Procedure or surgery | Group I; Conventional arthrocentesis followed by I-PRF injection |
| 3d surgical guided Arthrocentesis followed by I-PRF injectionPatients underwent arthrocentesis with Ringer lactate, followed by I-PRF injection in the TMJ's superior space using a CT-planned 3D-printed guide. Positioned at a 45° angle, patients were comfortably seated, and disinfection was performed. The patient-specific guide, fitting over maxillary teeth and the face, was employed unilaterally or bilaterally with a biting block for mouth opening maintenance. An 18-gauge needle administered 2-3 ml of Ringer lactate, widening the joint space, followed by a second needle allowing free solution flow (80-90 ml) to flush the superior joint space. Post-arthrocentesis, 1 ml of I-PRF was injected. To enhance joint mobility and free the disc, gentle manipulation of the lower jaw was performed after removing the needles and guide. | Procedure or surgery | Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection |
Primary outcome
Assessment of Pain
Time frame: Intraoperative,1 week, 1month and 3 months
Using visual analog scale
The number of needle insertion attempts
Time frame: Intraoperative
The number of needle insertions, indicative of the attempts, was counted for each group.
2 secondary outcomes
Maximal incisal opening
Time frame: 1 week, 1month and 3 months
Time of operation
Time frame: Intraoperative
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 15 Nov 2023.
- Background: PubMed 26929478Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998.
- Background: PubMed 29866452Laskin DM. Arthroscopy Versus Arthrocentesis for Treating Internal Derangements of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):325-328. doi: 10.1016/j.coms.2018.04.008. Epub 2018 Jun 1.
- Background: PubMed 32706994Custodio ALN, Cameron A, Bakr M, Little C, Chrcanovic BR, Reher P. Positioning accuracy assessment of minimally invasive percutaneous injection techniques for the treatment of temporomandibular disorders. Dentomaxillofac Radiol. 2021 Feb 1;50(2):20200313. doi: 10.1259/dmfr.20200313. Epub 2020 Jul 24.
- Background: PubMed 27118616Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.
- Background: PubMed 31705867Mahmoud K, Galal N, Ali S, Gibaly A, Elbehairy MS, Mounir M. Computer-Guided Arthrocentesis Using Patient-Specific Guides: A Novel Protocol for Treatment of Internal Derangement of the Temporomandibular Joint. J Oral Maxillofac Surg. 2020 Mar;78(3):372.e1-372.e7. doi: 10.1016/j.joms.2019.10.005. Epub 2019 Oct 15.
- Background: PubMed 35545190Hyder A, Tawfik BE, Elmohandes W. Efficacy of computer-guided versus conventional sodium hyaluronate injection in superior joint space in treatment of temporomandibular joint (TMJ) internal derangement: Comparative randomized controlled trial. J Stomatol Oral Maxillofac Surg. 2022 Oct;123(5):e321-e326. doi: 10.1016/j.jormas.2022.05.007. Epub 2022 May 8.
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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 Conventional arthrocentesis followed by I-PRF injection and 3d surgical guided Arthrocentesis followed by I-PRF injection in people with Temporomandibular Joint Disorders and Orofacial Pain, run by Al-Azhar 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 3 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 15 Nov 2023. 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?
Assessment of Pain (time frame: Intraoperative,1 week, 1month and 3 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?
On the ClinicalTrials.gov record for NCT06132594, which also lists 6 linked publications.
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 15 Nov 2023.