NCT06132594

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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

October 2, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 7, 2023

Last Update Submit

November 9, 2023

Conditions

Temporomandibular Joint DisordersOrofacial Pain

Keywords

TMDTemporomandibular Joint DisordersProlotherapy of TMJGuided Arthrocentesis

Outcome Measures

Primary Outcomes (2)

  • Assessment of Pain

    Using visual analog scale

    Intraoperative,1 week, 1month and 3 months

  • The number of needle insertion attempts

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

    Intraoperative

Secondary Outcomes (2)

  • Maximal incisal opening

    1 week, 1month and 3 months

  • Time of operation

    Intraoperative

Study Arms (2)

Group I; Conventional arthrocentesis followed by I-PRF injection

EXPERIMENTAL

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

Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection

EXPERIMENTAL

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

Interventions

Conventional arthrocentesis followed by I-PRF injectionPROCEDURE

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.

Group I; Conventional arthrocentesis followed by I-PRF injection
3d surgical guided Arthrocentesis followed by I-PRF injectionPROCEDURE

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.

Group II; 3d surgical guided Arthrocentesis followed by I-PRF injection

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine - Al-Azhar University

Asyut, Egypt

Location

Related Publications (6)

  • Young AL. Internal derangements of the temporomandibular joint: A review of the anatomy, diagnosis, and management. J Indian Prosthodont Soc. 2015 Jan-Mar;15(1):2-7. doi: 10.4103/0972-4052.156998.

    PMID: 26929478BACKGROUND

  • Laskin DM. Arthroscopy Versus Arthrocentesis for Treating Internal Derangements of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):325-328. doi: 10.1016/j.coms.2018.04.008. Epub 2018 Jun 1.

    PMID: 29866452BACKGROUND

  • Custodio ALN, Cameron A, Bakr M, Little C, Chrcanovic BR, Reher P. Positioning accuracy assessment of minimally invasive percutaneous injection techniques for the treatment of temporomandibular disorders. Dentomaxillofac Radiol. 2021 Feb 1;50(2):20200313. doi: 10.1259/dmfr.20200313. Epub 2020 Jul 24.

    PMID: 32706994BACKGROUND

  • Sivri MB, Ozkan Y, Pekiner FN, Gocmen G. Comparison of ultrasound-guided and conventional arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jul;54(6):677-81. doi: 10.1016/j.bjoms.2016.04.004. Epub 2016 Apr 23.

    PMID: 27118616BACKGROUND

  • Mahmoud K, Galal N, Ali S, Gibaly A, Elbehairy MS, Mounir M. Computer-Guided Arthrocentesis Using Patient-Specific Guides: A Novel Protocol for Treatment of Internal Derangement of the Temporomandibular Joint. J Oral Maxillofac Surg. 2020 Mar;78(3):372.e1-372.e7. doi: 10.1016/j.joms.2019.10.005. Epub 2019 Oct 15.

    PMID: 31705867BACKGROUND

  • Hyder A, Tawfik BE, Elmohandes W. Efficacy of computer-guided versus conventional sodium hyaluronate injection in superior joint space in treatment of temporomandibular joint (TMJ) internal derangement: Comparative randomized controlled trial. J Stomatol Oral Maxillofac Surg. 2022 Oct;123(5):e321-e326. doi: 10.1016/j.jormas.2022.05.007. Epub 2022 May 8.

    PMID: 35545190BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at the Department of oral and Maxillofacial Surgery

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 15, 2023

Study Start

October 2, 2021

Primary Completion

October 14, 2022

Study Completion

October 14, 2022

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

EG(1)