Temporomandibular Joint DisordersPhase 2NCT04557878
Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction
A Phase 2 study testing Hypertonic Dextrose Solution and Liquid Phase Concentrated Growth Factor (LPCGFs) in people with Temporomandibular Joint Disorders and Temporomandibular Disorder, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Disorder
- What is being tested?
- Hypertonic Dextrose Solution and Liquid Phase Concentrated Growth Factor (LPCGFs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2020to 1 Jun 2021
- Phase
- Phase 2
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with painful TMJ.
- Patients with limited mouth opening (MMO <40mm).
- Patients with anterior disc displacement without reduction confirmed by MRI.
- Presence of full or nearly full complement of natural teeth.
- Patients with angle class I occlusion.
- Patients with RCP not greater than 2mm and with no open bite.
Who cannot join
- Patients who have anterior disc dislocation with reduction detected by MRI.
- Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
- Patients having uncontrolled systemic disease, hematologic or neurologic disorders or inflammatory diseases.
- Patients under anticoagulant drug therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction (A Randomized Clinical Trial)
Purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for temporomandibular joint anterior disc displacement without reduction.
Read the detailed description
Twenty four patients with anterior disc displacement without reduction will be selected from those attending the Prosthodontic Department, Faculty of Dentistry, Alexandria University and diagnosed clinically and by magnetic resonance imaging. Patients will be randomly assigned into 2 study groups each comprising 12 patients. Group I will receive an intra-articular injection of hypertonic dextrose in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance while group II will receive an intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.
- Being tested
- Hypertonic Dextrose Solution, Liquid Phase Concentrated Growth Factor (LPCGFs)
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Dextrose SolutionDrug
Patients in this group will receive an intra-articular injection of 12.5% hypertonic dextrose solution, once every month for three consecutive months, in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.The point of needle entry will be 1 cm below the apex of the zygomatic arch and guided by ultrasound to ensure intra-articular injection in the superior joint space.
Liquid Phase Concentrated Growth Factor (LPCGFs)Biological
Patients in this group will receive single intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Dextrose Solution | Experimental | Not described Receives: Drug: Hypertonic Dextrose Solution |
| Liquid Phase Concentrated Growth Factor (LPCGFs) | Active comparator | Not described Receives: Biological: Liquid Phase Concentrated Growth Factor (LPCGFs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum mouth opening
This will be evaluated using Helkimo Anamnestic index (Ai) which comprises the following classes: Ai0 - absence of subjective symptoms of dysfunction; AiI -mild symptoms, such as TMJ sounds, including clicking and crepitation, and feelings of stiffness or fatigue of the jaws; and AiII - severe symptoms of dysfunction, such as difficulty in opening the mouth wide, locking, luxations, pain on movement, and facial and jaw pain.
Measured: up to 6 months
Disc-condyle relationship
This will be evaluated using magnetic resonance imaging (MRI) to assess the position of the articular disc and the condyle and the mandibular fossa
Measured: 6 months
Myeloperoxidase enzyme activity
This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.
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 posted22 Sep 2020
- Study start6 Oct 2020
- Primary completion1 Apr 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Mariam M. Bahgat, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptNadia R El-Helw, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptAhmed Abdelhamid, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptMohamed Fata, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptMedhat Ashour, PhD, Study director, High Institute of Public Health, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557878
- Sponsor's protocol ID
- LPGF vs hypertonic dextrose
- Status last verified
- Dec 2023
- First submitted
- 15 Sep 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bahgat MM, El-Helw NR, Abdel-Hamid AM, Fata MM, Ashour MS, Atteya AM. Synovial fluid level of myeloperoxidase enzyme following ultrasound-guided regenerative injections in patients with irreducible temporomandibular disc displacement: a double-blinded parallel randomized clinical trial. BMC Oral Health. 2026 Jul 20;26(1):1312. doi: 10.1186/s12903-026-09266-7.
PubMed 42472796
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04557878
- Acronym / sponsor ID
- LPGF vs hypertonic dextrose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Sep 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.
Purpose of the study is to compare clinically, radiographically and biochemically the effect of intra- articular injection of hypertonic dextrose with a stabilization appliance and the intra- articular injection of 2 ml of liquid phase concentrated growth factor with a stabilization appliance as a prolotherapy for temporomandibular joint anterior disc displacement without reduction.
Detailed description
Twenty four patients with anterior disc displacement without reduction will be selected from those attending the Prosthodontic Department, Faculty of Dentistry, Alexandria University and diagnosed clinically and by magnetic resonance imaging. Patients will be randomly assigned into 2 study groups each comprising 12 patients. Group I will receive an intra-articular injection of hypertonic dextrose in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance while group II will receive an intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Dextrose Solution | Experimental | Drug: Hypertonic Dextrose Solution |
| Liquid Phase Concentrated Growth Factor (LPCGFs) | Active comparator | Biological: Liquid Phase Concentrated Growth Factor (LPCGFs) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with painful TMJ.
- Patients with limited mouth opening (MMO <40mm).
- Patients with anterior disc displacement without reduction confirmed by MRI.
- Presence of full or nearly full complement of natural teeth.
- Patients with angle class I occlusion.
Key exclusion criteria (4 listed)
- Patients who have anterior disc dislocation with reduction detected by MRI.
- Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
- Patients having uncontrolled systemic disease, hematologic or neurologic disorders or inflammatory diseases.
- Patients under anticoagulant drug therapy.
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 |
|---|---|---|
| Hypertonic Dextrose SolutionPatients in this group will receive an intra-articular injection of 12.5% hypertonic dextrose solution, once every month for three consecutive months, in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.The point of needle entry will be 1 cm below the apex of the zygomatic arch and guided by ultrasound to ensure intra-articular injection in the superior joint space. | Drug | Hypertonic Dextrose Solution |
| Liquid Phase Concentrated Growth Factor (LPCGFs)Patients in this group will receive single intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance. | Biological | Liquid Phase Concentrated Growth Factor (LPCGFs) |
Primary outcome
Maximum mouth opening
Time frame: up to 6 months
This will be evaluated using Helkimo Anamnestic index (Ai) which comprises the following classes: Ai0 - absence of subjective symptoms of dysfunction; AiI -mild symptoms, such as TMJ sounds, including clicking and crepitation, and feelings of stiffness or fatigue of the jaws; and AiII - severe symptoms of dysfunction, such as difficulty in opening the mouth wide, locking, luxations, pain on movement, and facial and jaw pain.
Disc-condyle relationship
Time frame: 6 months
This will be evaluated using magnetic resonance imaging (MRI) to assess the position of the articular disc and the condyle and the mandibular fossa
Myeloperoxidase enzyme activity
Time frame: 6 months
This will be evaluated by using Myeloperoxidase enzyme assay kits for detection and quantitation of myeloperoxidase activity levels.
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 Dec 2023.
- Derived from this study: PubMed 42472796Bahgat MM, El-Helw NR, Abdel-Hamid AM, Fata MM, Ashour MS, Atteya AM. Synovial fluid level of myeloperoxidase enzyme following ultrasound-guided regenerative injections in patients with irreducible temporomandibular disc displacement: a double-blinded parallel randomized clinical trial. BMC Oral Health. 2026 Jul 20;26(1):1312. doi: 10.1186/s12903-026-09266-7.
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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.
Mariam M. Bahgat, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Nadia R El-Helw, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Ahmed Abdelhamid, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypertonic Dextrose Solution and Liquid Phase Concentrated Growth Factor (LPCGFs) in people with Temporomandibular Joint Disorders and Temporomandibular Disorder, run by Nourhan M.Aly 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 4 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 Dec 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum mouth opening (time frame: up to 6 months). The study lists 3 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 NCT04557878, which also lists 1 linked publication.
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 Dec 2023.