Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation
NCT ID: NCT03655275
Last Updated: 2018-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
EARLY_PHASE1
22 participants
INTERVENTIONAL
2018-08-24
2019-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders
NCT03371888
Intra-articular Magnesium Sulfate for Tmj Dysfunction
NCT03675659
Platelet-rich Plasma Injection for Temporomandibular Disorders
NCT04127942
Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders
NCT04317560
Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients
NCT02397070
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group(A): PRP
PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular
PRP prolotherapy
PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
Group (B): saline
Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular
Saline prolotherapy
Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRP prolotherapy
PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
Saline prolotherapy
Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 18 years
3. Willingness of the patient to receive relative painful injections and to follow instructions.
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Abdelrahman Soliman Alateyh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abdelrahman Soliman Alateyh
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hamida R Hassanien, phd
Role: STUDY_DIRECTOR
Cairo University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Oral and Dental Medicine
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Abdelrahman S Alatyeh, B.D.S
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Pihut 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.
Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. No abstract available.
Yelland 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TMJ prolotherapy
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.