Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation
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|ClinicalTrials.gov Identifier: NCT03655275|
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Disorders||Biological: PRP prolotherapy Biological: Saline prolotherapy||Early Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is randomized, placebo controlled trial.|
|Masking:||None (Open Label)|
|Masking Description:||This study is randomized, placebo controlled trial.|
|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|
|Estimated Study Start Date :||August 24, 2018|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||May 30, 2019|
Active Comparator: Group(A): PRP
PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular
Biological: PRP prolotherapy
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
Biological: Saline prolotherapy
Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
- Patients' subjective pain experience [ Time Frame: up to 40 weeks ]visual anlogue scale (VAS) from 0 - 10
- Frequency of luxation [ Time Frame: up to 40 weeks ]The number of luxation/day
- Maximum mouth opening [ Time Frame: up to 40 weeks ]ruler per mm from 0 - 70
- Joint sounds [ Time Frame: up to 40 weeks ]preauricular palpation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655275
|Contact: abdelrahman alatyeh, B.D.Semail@example.com|
|Faculty of Oral and Dental Medicine||Recruiting|
|Cairo, Egypt, 0020|
|Contact: Abdelrahman S Alatyeh, B.D.S|
|Contact: mohammed Alatyeh 00201097114252 firstname.lastname@example.org|
|Study Director:||Hamida R Hassanien, phd||Cairo University|