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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

Tracking Information
First Submitted Date  ICMJE August 26, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date August 31, 2018
Estimated Study Start Date  ICMJE August 24, 2018
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Patients' subjective pain experience [ Time Frame: up to 40 weeks ]
visual anlogue scale (VAS) from 0 - 10
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation
Official Title  ICMJE The Effects of Platelet-rich Plasma Prolotherapy on Pain Score and Frequency of Luxation in Temporomandibular Joint Subluxation A Prospective Randomized Placebo Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE Temporomandibular Joint Disorders
Intervention  ICMJE
  • Biological: PRP prolotherapy
    PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
  • Biological: Saline prolotherapy
    Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
Study Arms  ICMJE
  • Active Comparator: Group(A): PRP
    PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular
    Intervention: Biological: PRP prolotherapy
  • Active Comparator: Group (B): saline
    Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular
    Intervention: Biological: Saline prolotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2019
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: abdelrahman alatyeh, B.D.S 00201099179039 abo.noorsyria@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03655275
Other Study ID Numbers  ICMJE TMJ prolotherapy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Abdelrahman Soliman Alateyh, Cairo University
Study Sponsor  ICMJE Abdelrahman Soliman Alateyh
Collaborators  ICMJE Cairo University
Investigators  ICMJE
Study Director: Hamida R Hassanien, phd Cairo University
PRS Account Cairo University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP