NCT03655275

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

August 26, 2018

Last Update Submit

August 30, 2018

Conditions

Temporomandibular Joint Disorders

Keywords

subluxation , platelet rich plasma (PRP), prolotherapy.

Outcome Measures

Primary Outcomes (1)

  • Patients' subjective pain experience

    visual anlogue scale (VAS) from 0 - 10

    up to 40 weeks

Secondary Outcomes (3)

  • Frequency of luxation

    up to 40 weeks

  • Maximum mouth opening

    up to 40 weeks

  • Joint sounds

    up to 40 weeks

Study Arms (2)

Group(A): PRP

ACTIVE COMPARATOR

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

Biological: PRP prolotherapy

Group (B): saline

ACTIVE COMPARATOR

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

Biological: Saline prolotherapy

Interventions

PRP prolotherapyBIOLOGICAL

PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.

Group(A): PRP
Saline prolotherapyBIOLOGICAL

Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.

Group (B): saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. Patients with dystonia 2. Drug induced TMJ hypermobility 3. Medical conditions that could significantly interfere with treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, 0020, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23576936BACKGROUND

  • 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.

    PMID: 25157351BACKGROUND

  • Jureidini J. Is there a role for placebo analgesia? N Z Med J. 2003 Aug 8;116(1179):U541. No abstract available.

    PMID: 14513087BACKGROUND

  • 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.

    PMID: 14699269BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersJoint Dislocations

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesWounds and Injuries

Study Officials

  • Hamida R Hassanien, phd

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

abdelrahman alatyeh, B.D.S

CONTACT

00201099179039abo.noorsyria@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is randomized, placebo controlled trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is randomized, placebo controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2018

First Posted

August 31, 2018

Study Start

August 24, 2018

Primary Completion

September 30, 2018

Study Completion

May 30, 2019

Last Updated

September 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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

Locations

EG(1)