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NCT Number: NCT06132594

Computed Guided Prolotherapy Versus Conventional Prolotherapy

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

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Orofacial Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine - Al-Azhar University

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional arthrocentesis followed by I-PRF injection

Procedure

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.

3d surgical guided Arthrocentesis followed by I-PRF injection

Procedure

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.

Primary outcomes

  1. Assessment of Pain

    Time frame: Intraoperative,1 week, 1month and 3 months

    Using visual analog scale

  2. The number of needle insertion attempts

    Time frame: Intraoperative

    The number of needle insertions, indicative of the attempts, was counted for each group.

Secondary outcomes

  1. Maximal incisal opening

    Time frame: 1 week, 1month and 3 months

    Using digital caliper in Millimeter (mm)

  2. Time of operation

    Time frame: Intraoperative

    In minutes

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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