Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation

Temporomandibular Joint Disorders Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655275
• Other study ID #: TMJ prolotherapy
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 24, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: abdelrahman alatyeh, B.D.S
• Phone: 00201099179039
• Email: abo.noorsyria[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to clinically assess the efficacy of PRP prolotherapy for treatment of TMJ subluxation

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: May 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Abdelrahman Soliman Alateyh	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' subjective pain experience	visual anlogue scale (VAS) from 0 - 10	up to 40 weeks
Secondary	Frequency of luxation	The number of luxation/day	up to 40 weeks
Secondary	Maximum mouth opening	ruler per mm from 0 - 70	up to 40 weeks
Secondary	Joint sounds	preauricular palpation	up to 40 weeks