Temporomandibular Joint DisordersEarly Phase 1NCT03655275
Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation
A Early Phase 1 study testing PRP prolotherapy and Saline prolotherapy in people with Temporomandibular Joint Disorders, run by Abdelrahman Soliman Alateyh at 1 site in Egypt.
Trial summary
The aim of this study is to clinically assess the efficacy of PRP prolotherapy for treatment of TMJ subluxation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- PRP prolotherapy and Saline prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2018to 30 May 2019
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had TMJ subluxation for at least six months.
- Age ≥ 18 years
- Willingness of the patient to receive relative painful injections and to follow instructions.
Who cannot join
- 1. Patients with dystonia 2. Drug induced TMJ hypermobility 3. Medical conditions that could significantly interfere with treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine
Cairo, 0020
Abdelrahman S Alatyeh, B.D.S
mohammed Alatyeh, 00201097114252, abdelrahman.soliman@dentistry.cu.edu.eg
About this study
Official title: The Effects of Platelet-rich Plasma Prolotherapy on Pain Score and Frequency of Luxation in Temporomandibular Joint Subluxation A Prospective Randomized Placebo Controlled Trial
The aim of this study is to clinically assess the efficacy of PRP prolotherapy for treatment of TMJ subluxation
Read the detailed description
The effect of platelet-rich plasma prolotherapy on the pain score and frequency of luxation in temporomandibular joint subluxation. A prospective randomized placebo controlled trial
- After detailed clinical evaluation, every patient will undergo routine preoperative laboratory tests (complete blood cell count, HCV , HBV , Tomogram of TMJ examination). In cases in which special diagnostic procedures will be needed for more detailed evaluation of the patients, they will also be performed.
- All cases will undergo to withdraw 40 ml of blood from the patient's upper limb cubital vein using an 18G needle, subsequently 5 ml of citrate sodium solution is added to the sample as an anticoagulant. One milliliter of the blood sample will be sent for complete blood count.
- To prepare of high concentration PRP the blood sample will be then centrifuged for 15 minutes at 1600 rpm resulting in three layers: the lower layer made up of red blood cells, the intermediate layer is composed of white blood cells, and the upper layer is composed of plasma. The Buffy coat layer and the plasma layer will be later collected and centrifuged for another 7 minutes at 2800 rpm in order to concentrate platelets. The final product will be about 4-6 mL of PRP containing leukocytes.
- the skin surface of the preauricular area will be disinfected with Betadine surgical scrub solution. The anatomic landmarks will be located by asking the patient to open widely to allow drawing of the articular fossa and then to close lightly on the posterior teeth to draw the condyle within the glenoid fossa.
- Typically, each joint had 3 injection sites:
- The needle will be inserted at lateral margin of the glenoid fossa and 0.5 ml of the PRP will be slowly injected at the superior capsular attachment .Then needle will be directed immediately under the lateral margin of the glenoid fossa superiorly and medially toward the apex of the fossa.1ml of the PRP will be then slowly injected into the superior joint space
- The needle will be inserted at the condylar neck and 0.5 ml of the PRP will be injected at the inferior capsular attachment. Then needle will be directed superficial to the TMJ capsule, 0.5 ml of the PRP will be deposited as needle will be withdrawn.
- patients in the placebo group received injections of placebo (saline) using the same volume on the same schedule.
- Post operative care and instructions:
- Bleeding from the injection sites will be generally minimal and could be controlled with direct pressure on the injection site for a few seconds.
- All patients will be advised to take "paracetamol", one tablet when needed and to stop the use of other pain and anti-inflammatory drugs during the treatment phase.
- Each patient will be instructed to receive soft diet only for two weeks in order to decrease the effort upon TMJ .
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- PRP prolotherapy, Saline prolotherapy
- Keywords
- subluxation , platelet rich plasma (PRP), prolotherapy.
- Medical subject headings
- Temporomandibular Joint Disorders, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP prolotherapyBiological
PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
Saline prolotherapyBiological
Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group(A): PRP | Active comparator | PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular Receives: Biological: PRP prolotherapy |
| Group (B): saline | Active comparator | Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular Receives: Biological: Saline prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' subjective pain experience
visual anlogue scale (VAS) from 0 - 10
Measured: up to 40 weeks
Secondary outcomes (3)
Frequency of luxation
The number of luxation/day
Measured: up to 40 weeks
Maximum mouth opening
ruler per mm from 0 - 70
Measured: up to 40 weeks
Joint sounds
preauricular palpation
Measured: up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start24 Aug 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is randomized, placebo controlled trial.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Soliman Alateyh
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Abdelrahman Soliman Alateyh, Cairo University
- Investigators
- Hamida R Hassanien, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655275
- Sponsor's protocol ID
- TMJ prolotherapy
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Group A : each joint will receive 2 session of intrarticular and pericapsular injections with 2.5ml of PRP at interval of 2 weeks. • Group B : : each joint will receive 2 session of intrarticular and pericapsular injections with 2.5ml of PRP at interval of 2 weeks.
Publications
Middleton KK, Barro V, Muller B, Terada S, Fu FH. Evaluation of the effects of platelet-rich plasma (PRP) therapy involved in the healing of sports-related soft tissue injuries. Iowa Orthop J. 2012;32:150-63.
PubMed 23576936Pihut M, Szuta M, Ferendiuk E, Zenczak-Wieckiewicz D. Evaluation of pain regression in patients with temporomandibular dysfunction treated by intra-articular platelet-rich plasma injections: a preliminary report. Biomed Res Int. 2014;2014:132369. doi: 10.1155/2014/132369. Epub 2014 Aug 3.
PubMed 25157351Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. No abstract available.
PubMed 14513087Yelland MJ, Glasziou PP, Bogduk N, Schluter PJ, McKernon M. Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial. Spine (Phila Pa 1976). 2004 Jan 1;29(1):9-16; discussion 16. doi: 10.1097/01.BRS.0000105529.07222.5B.
PubMed 14699269
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Platelet-rich Plasma Prolotherapy on Pain Score and Frequency of Luxation in Temporomandibular Joint Subluxation A Prospective Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03655275
- Acronym / sponsor ID
- TMJ prolotherapy
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- subluxation , platelet rich plasma (PRP), prolotherapy.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Abdelrahman Soliman AlateyhUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 24 Aug 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 31 Aug 2018 (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 this study is to clinically assess the efficacy of PRP prolotherapy for treatment of TMJ subluxation
Detailed description
The effect of platelet-rich plasma prolotherapy on the pain score and frequency of luxation in temporomandibular joint subluxation. A prospective randomized placebo controlled trial
- After detailed clinical evaluation, every patient will undergo routine preoperative laboratory tests (complete blood cell count, HCV , HBV , Tomogram of TMJ examination). In cases in which special diagnostic procedures will be needed for more detailed evaluation of the patients, they will also be performed.
- All cases will undergo to withdraw 40 ml of blood from the patient's upper limb cubital vein using an 18G needle, subsequently 5 ml of citrate sodium solution is added to the sample as an anticoagulant. One milliliter of the blood sample will be sent for complete blood count.
- To prepare of high concentration PRP the blood sample will be then centrifuged for 15 minutes at 1600 rpm resulting in three layers: the lower layer made up of red blood cells, the intermediate layer is composed of white blood cells, and the upper layer is composed of plasma. The Buffy coat layer and the plasma layer will be later collected and centrifuged for another 7 minutes at 2800 rpm in order to concentrate platelets. The final product will be about 4-6 mL of PRP containing leukocytes.
- the skin surface of the preauricular area will be disinfected with Betadine surgical scrub solution. The anatomic landmarks will be located by asking the patient to open widely to allow drawing of the articular fossa and then to close lightly on the posterior teeth to draw the condyle within the glenoid fossa.
- Typically, each joint had 3 injection sites:
- The needle will be inserted at lateral margin of the glenoid fossa and 0.5 ml of the PRP will be slowly injected at the superior capsular attachment .Then needle will be directed immediately under the lateral margin of the glenoid fossa superiorly and medially toward the apex of the fossa.1ml of the PRP will be then slowly injected into the superior joint space
- The needle will be inserted at the condylar neck and 0.5 ml of the PRP will be injected at the inferior capsular attachment. Then needle will be directed superficial to the TMJ capsule, 0.5 ml of the PRP will be deposited as needle will be withdrawn.
- patients in the placebo group received injections of placebo (saline) using the same volume on the same schedule.
- Post operative care and instructions:
- Bleeding from the injection sites will be generally minimal and could be controlled with direct pressure on the injection site for a few seconds.
- All patients will be advised to take "paracetamol", one tablet when needed and to stop the use of other pain and anti-inflammatory drugs during the treatment phase.
- Each patient will be instructed to receive soft diet only for two weeks in order to decrease the effort upon TMJ .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is randomized, placebo controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Group(A): PRP | Active comparator | Biological: PRP prolotherapyPRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular |
| Group (B): saline | Active comparator | Biological: Saline prolotherapySaline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who had TMJ subluxation for at least six months.
- Age ≥ 18 years
- Willingness of the patient to receive relative painful injections and to follow instructions.
Key exclusion criteria (1 listed)
- 1. Patients with dystonia 2. Drug induced TMJ hypermobility 3. Medical conditions that could significantly interfere with treatment
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 |
|---|---|---|
| PRP prolotherapyPRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks. | Biological | Group(A): PRP |
| Saline prolotherapySaline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks. | Biological | Group (B): saline |
Primary outcome
Patients' subjective pain experience
Time frame: up to 40 weeks
visual anlogue scale (VAS) from 0 - 10
3 secondary outcomes
Frequency of luxation
Time frame: up to 40 weeks
Maximum mouth opening
Time frame: up to 40 weeks
Joint sounds
Time frame: up to 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Background: PubMed 23576936Middleton KK, Barro V, Muller B, Terada S, Fu FH. Evaluation of the effects of platelet-rich plasma (PRP) therapy involved in the healing of sports-related soft tissue injuries. Iowa Orthop J. 2012;32:150-63.
- Background: PubMed 25157351Pihut M, Szuta M, Ferendiuk E, Zenczak-Wieckiewicz D. Evaluation of pain regression in patients with temporomandibular dysfunction treated by intra-articular platelet-rich plasma injections: a preliminary report. Biomed Res Int. 2014;2014:132369. doi: 10.1155/2014/132369. Epub 2014 Aug 3.
- Background: PubMed 14513087Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. No abstract available.
- Background: PubMed 14699269Yelland MJ, Glasziou PP, Bogduk N, Schluter PJ, McKernon M. Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial. Spine (Phila Pa 1976). 2004 Jan 1;29(1):9-16; discussion 16. doi: 10.1097/01.BRS.0000105529.07222.5B.
- Individual participant dataSharing planned: Yes. Group A : each joint will receive 2 session of intrarticular and pericapsular injections with 2.5ml of PRP at interval of 2 weeks. • Group B : : each joint will receive 2 session of intrarticular and pericapsular injections with 2.5ml of PRP at interval of 2 weeks.
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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.
Hamida R Hassanien, phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PRP prolotherapy and Saline prolotherapy in people with Temporomandibular Joint Disorders, run by Abdelrahman Soliman Alateyh 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 1 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: status not confirmed, as of the sponsor's last update on 4 Sep 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abdelrahman alatyeh, B.D.S (00201099179039, abo.noorsyria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' subjective pain experience (time frame: up to 40 weeks). 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 NCT03655275, which also lists 4 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 4 Sep 2018.