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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
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Abdelrahman Soliman Alateyh, Cairo University

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

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Biological: PRP prolotherapy Biological: Saline prolotherapy Early Phase 1

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

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
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.




Primary Outcome Measures :
  1. Patients' subjective pain experience [ Time Frame: up to 40 weeks ]
    visual anlogue scale (VAS) from 0 - 10


Secondary Outcome Measures :
  1. Frequency of luxation [ Time Frame: up to 40 weeks ]
    The number of luxation/day

  2. Maximum mouth opening [ Time Frame: up to 40 weeks ]
    ruler per mm from 0 - 70

  3. Joint sounds [ Time Frame: up to 40 weeks ]
    preauricular palpation



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: abdelrahman alatyeh, B.D.S 00201099179039 abo.noorsyria@gmail.com

Locations
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Egypt
Faculty of Oral and Dental Medicine Recruiting
Cairo, Egypt, 0020
Contact: Abdelrahman S Alatyeh, B.D.S         
Contact: mohammed Alatyeh    00201097114252    abdelrahman.soliman@dentistry.cu.edu.eg   
Sponsors and Collaborators
Abdelrahman Soliman Alateyh
Cairo University
Investigators
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Study Director: Hamida R Hassanien, phd Cairo University

Publications:
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Responsible Party: Abdelrahman Soliman Alateyh, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03655275     History of Changes
Other Study ID Numbers: TMJ prolotherapy
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: few months to year
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

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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
Keywords provided by Abdelrahman Soliman Alateyh, Cairo University:
subluxation , platelet rich plasma (PRP), prolotherapy.
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Dislocations
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Wounds and Injuries