Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation

Early Phase 1

• Conditions: Temporomandibular Joint Disorders
• Interventions: Biological: PRP prolotherapy; Biological: Saline prolotherapy

• Registration Number: NCT03655275
• Lead Sponsor: Abdelrahman Soliman Alateyh

Brief Summary

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 Timeline

• Status Verified: 2018-08
• Study Start: 2018-08-24
• Study First Submitted: 2018-08-26
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-09-04
• Primary Completion: 2018-09-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Patients who had TMJ subluxation for at least six months.
2. Age ≥ 18 years
3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group(A): PRP	PRP prolotherapy	PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular
Group (B): saline	Saline prolotherapy	Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular

Primary Outcome Measures

Name	Time	Method
Patients' subjective pain experience	up to 40 weeks	visual anlogue scale (VAS) from 0 - 10

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening	up to 40 weeks	ruler per mm from 0 - 70
Joint sounds	up to 40 weeks	preauricular palpation
Frequency of luxation	up to 40 weeks	The number of luxation/day

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine; 🇪🇬 Cairo, Egypt