Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation
August 30, 2018 updated by: Abdelrahman Soliman Alateyh
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
22
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 0020
- Recruiting
- Faculty of Oral and Dental Medicine
-
Contact:
- Abdelrahman S Alatyeh, B.D.S
-
Contact:
- mohammed Alatyeh
- Phone Number: 00201097114252
- Email: abdelrahman.soliman@dentistry.cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1. Patients with dystonia 2. Drug induced TMJ hypermobility 3. Medical conditions that could significantly interfere with treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group(A): PRP
PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks.
Intraticular and pericapsular
|
PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
|
|
Active Comparator: Group (B): saline
Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular
and pericapsular
|
Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' subjective pain experience
Time Frame: up to 40 weeks
|
visual anlogue scale (VAS) from 0 - 10
|
up to 40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of luxation
Time Frame: up to 40 weeks
|
The number of luxation/day
|
up to 40 weeks
|
|
Maximum mouth opening
Time Frame: up to 40 weeks
|
ruler per mm from 0 - 70
|
up to 40 weeks
|
|
Joint sounds
Time Frame: up to 40 weeks
|
preauricular palpation
|
up to 40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Hamida R Hassanien, phd, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 24, 2018
Primary Completion (Anticipated)
September 30, 2018
Study Completion (Anticipated)
May 30, 2019
Study Registration Dates
First Submitted
August 26, 2018
First Submitted That Met QC Criteria
August 30, 2018
First Posted (Actual)
August 31, 2018
Study Record Updates
Last Update Posted (Actual)
September 4, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMJ prolotherapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
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.
IPD Sharing Time Frame
few months to year
IPD Sharing Access Criteria
The effects of platelet-rich plasma prolotherapy on pain score and frequency of luxation in temporomandibular joint subluxation A prospective randomized placebo controlled trial
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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