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Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
PRP prolotherapy
Saline prolotherapy
Sponsored by
Abdelrahman Soliman Alateyh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring subluxation , platelet rich plasma (PRP), prolotherapy.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Oral and Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group(A): PRP

Group (B): saline

Arm Description

PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular

Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular

Outcomes

Primary Outcome Measures

Patients' subjective pain experience
visual anlogue scale (VAS) from 0 - 10

Secondary Outcome Measures

Frequency of luxation
The number of luxation/day
Maximum mouth opening
ruler per mm from 0 - 70
Joint sounds
preauricular palpation

Full Information

First Posted
August 26, 2018
Last Updated
August 30, 2018
Sponsor
Abdelrahman Soliman Alateyh
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03655275
Brief Title
Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2018 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abdelrahman Soliman Alateyh
Collaborators
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
subluxation , platelet rich plasma (PRP), prolotherapy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This study is randomized, placebo controlled trial.
Masking
None (Open Label)
Masking Description
This study is randomized, placebo controlled trial.
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group(A): PRP
Arm Type
Active Comparator
Arm Description
PRP prolotherapy injections with 2.5ml of PRP at an interval of 2 weeks. Intraticular and pericapsular
Arm Title
Group (B): saline
Arm Type
Active Comparator
Arm Description
Saline prolotherapy injections with 2.5ml of saline at an interval of 2 weeks.intrarticular and pericapsular
Intervention Type
Biological
Intervention Name(s)
PRP prolotherapy
Intervention Description
PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
Intervention Type
Biological
Intervention Name(s)
Saline prolotherapy
Intervention Description
Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
Primary Outcome Measure Information:
Title
Patients' subjective pain experience
Description
visual anlogue scale (VAS) from 0 - 10
Time Frame
up to 40 weeks
Secondary Outcome Measure Information:
Title
Frequency of luxation
Description
The number of luxation/day
Time Frame
up to 40 weeks
Title
Maximum mouth opening
Description
ruler per mm from 0 - 70
Time Frame
up to 40 weeks
Title
Joint sounds
Description
preauricular palpation
Time Frame
up to 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had TMJ subluxation for at least six months. Age ≥ 18 years 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abdelrahman alatyeh, B.D.S
Phone
00201099179039
Email
abo.noorsyria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamida R Hassanien, phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine
City
Cairo
ZIP/Postal Code
0020
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelrahman S Alatyeh, B.D.S
First Name & Middle Initial & Last Name & Degree
mohammed Alatyeh
Phone
00201097114252
Email
abdelrahman.soliman@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
few months to year
IPD Sharing 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
Citations:
PubMed Identifier
23576936
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.
Results Reference
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PubMed Identifier
25157351
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.
Results Reference
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PubMed Identifier
14513087
Citation
Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. No abstract available.
Results Reference
background
PubMed Identifier
14699269
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. doi: 10.1097/01.BRS.0000105529.07222.5B.
Results Reference
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Effects of Platelet-rich Plasma Prolotherapy of Temporomandibular Joint Subluxation

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