Computed Guided Prolotherapy Versus Conventional Prolotherapy

November 9, 2023 updated by: Zahran Arafat Ahmed Arafat, Al-Azhar University

Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment

The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).

Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.

Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.

Preparation of I-PRF:

The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt
        • Faculty of Dental Medicine - Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Bilateral or unilateral TMJ internal derangement.
  • No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
  • Ability to undergo MRI or CT scans without contraindications.

Exclusion Criteria:

  • Those with systemic diseases (polyarthritis or rheumatoid diseases).
  • Individuals with neurologic disorders.
  • Patients with a history of condylar fracture or previous TMJ injections.
  • Those with head and neck cancer.
  • Completely edentulous patients (lacking teeth).
  • Individuals with implanted metal or medical devices.
  • Patients with developmental and congenital disorders of the TMJ.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I; Conventional arthrocentesis followed by I-PRF injection
Patients received arthrocentesis followed by I-PRF injection, employing the conventional TMJ injection technique aided by facial anatomical landmarks
Procedure: Conventional arthrocentesis followed by I-PRF injection
An auriculotemporal nerve block using Mebacaine 0.5% was administered near the mandible's neck. The patient sat at a 45° angle with their head turned. The posterior entry point was 10 mm from the midtragus and 2 mm below the line, while the anterior entry point was marked 20 mm from the midtragus and 10 mm below the line. A biting block kept the mouth open. 2-3 ml of Ringer lactate was injected with an 18-gauge needle to enlarge the joint space. A second needle allowed the solution to flow freely. After lavaging the joint, 1 ml of I-PRF was injected into the upper joint space. Jaw manipulation was done to address adhesions and improve disc mobility.
Experimental: Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection
Patients received arthrocentesis followed by I-PRF injection with the assistance of a CT-guided 3D printed surgical guide.
Procedure: 3d surgical guided Arthrocentesis followed by I-PRF injection
Patients underwent arthrocentesis with Ringer lactate, followed by I-PRF injection in the TMJ's superior space using a CT-planned 3D-printed guide. Positioned at a 45° angle, patients were comfortably seated, and disinfection was performed. The patient-specific guide, fitting over maxillary teeth and the face, was employed unilaterally or bilaterally with a biting block for mouth opening maintenance. An 18-gauge needle administered 2-3 ml of Ringer lactate, widening the joint space, followed by a second needle allowing free solution flow (80-90 ml) to flush the superior joint space. Post-arthrocentesis, 1 ml of I-PRF was injected. To enhance joint mobility and free the disc, gentle manipulation of the lower jaw was performed after removing the needles and guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Pain
Time Frame: Intraoperative,1 week, 1month and 3 months
Using visual analog scale
Intraoperative,1 week, 1month and 3 months
The number of needle insertion attempts
Time Frame: Intraoperative
The number of needle insertions, indicative of the attempts, was counted for each group.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal incisal opening
Time Frame: 1 week, 1month and 3 months
Using digital caliper in Millimeter (mm)
1 week, 1month and 3 months
Time of operation
Time Frame: Intraoperative
In minutes
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2021

Primary Completion (Actual)

October 14, 2022

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUAREC20210100-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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