NCT06132802

Brief Summary

The study aims to evaluate clinically and radiographically the effectiveness of arthrocentesis and injection of I-PRF with wearing ARS in comparison to arthrocentesis and ARS only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

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 10, 2023

Completed
5 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 10, 2023

Last Update Submit

November 10, 2023

Conditions

Temporomandibular Joint Disorders

Keywords

Anterior repositioning guided splintInjectable platelet-rich fibrin

Outcome Measures

Primary Outcomes (2)

  • Maximum mouth opening

    Maximum Mouth Opening was determined by measuring the distance between the incisal edges of the upper and lower incisors. In Millimeter (mm)

    First week, first month, third months, and sixth months

  • Pain score

    Using Visual Analogue Scale (VAS)

    First week, first month, third months, and sixth months

Secondary Outcomes (1)

  • Right and left lateral excursion

    First week, first month, third months, and sixth months

Study Arms (2)

Group I: Patients who received treatment involving ARS and arthrocentesis only

EXPERIMENTAL
Procedure: Patients who received treatment involving ARS and arthrocentesis only

Group II: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection

EXPERIMENTAL
Procedure: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection

Interventions

Patients who received treatment involving ARS and arthrocentesis onlyPROCEDURE

A 5mm acrylic anterior repositioning splint (ARS) with maxillary coverage was crafted from alginate impressions. After arthrocentesis, the ARS was worn incrementally over six months, starting at two hours and reaching 14 hours daily. In the second week, wear time was continuous, increasing to 24 hours daily (excluding meals) until the sixth month. The ramp was removed in the seventh week. Follow-ups involved grinding the splint by 1mm every four weeks. Arthrocentesis included anesthesia, betadine prep, and using two 18-gauge needles to inject Ringer's lactate solution (100-200 cc) for joint lavage, freeing the disc by moving the lower jaw in various orientations.

Group I: Patients who received treatment involving ARS and arthrocentesis only
Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injectionPROCEDURE

A 5mm acrylic anterior repositioning splint (ARS) was crafted from alginate impressions, secured with Adam's clasps on upper first molars. After arthrocentesis, patients wore the splint incrementally over six months, starting at two hours and reaching 24 hours daily (excluding meals). The ramp was removed in the seventh week, and follow-ups included grinding the splint by 1mm every four weeks until it reached 3mm, guided by articulating paper. Arthrocentesis involved administering anesthesia, prepping the area with betadine, and using two 18-gauge needles to inject 2-3 ml of Ringer's lactate solution for joint lavage. The lower jaw was moved to free the disc and release fibrous tissue. I-PRF preparation included centrifuging collected blood for 3 minutes at 700 rpm, and the resulting I-PRF was injected into the superior joint space of the lavaged joints.

Group II: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years and older.
  • History of unilateral or bilateral disc displacement without reduction (DDwoR) of the temporomandibular joint (TMJ) confirmed by MRI.
  • Presence of TMJ pain and restricted maximum mouth opening.
  • No improvement with conservative treatment.
  • Absence of MRI contraindications.

You may not qualify if:

  • Patients having any systemic disease that could interfere with the TMJ treatment or assessment.
  • Patients having previous TMD treatment modalities or previous TMJ surgery.
  • Patients with a previous history of oral and or maxillofacial trauma.
  • Patients that are contraindicated to perform MRI.
  • Completely or partially edentulous patients were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine Al-Azhar University

Asyut, Egypt

Location

Related Publications (5)

  • Yuce E, Komerik N. Comparison of the Efficiacy of Intra-Articular Injection of Liquid Platelet-Rich Fibrin and Hyaluronic Acid After in Conjunction With Arthrocentesis for the Treatment of Internal Temporomandibular Joint Derangements. J Craniofac Surg. 2020 Oct;31(7):1870-1874. doi: 10.1097/SCS.0000000000006545.

    PMID: 32433129BACKGROUND

  • Herrera-Vizcaino C, Dohle E, Al-Maawi S, Booms P, Sader R, Kirkpatrick CJ, Choukroun J, Ghanaati S. Platelet-rich fibrin secretome induces three dimensional angiogenic activation in vitro. Eur Cell Mater. 2019 Apr 9;37:250-264. doi: 10.22203/eCM.v037a15.

    PMID: 30963526BACKGROUND

  • Teama UA. Evaluation of Injectable platelet rich fibrin for the management of Tempromandibular joint internal derangement.(clinical evaluation). Egy Dent J. 2020; 66:883-91.

    BACKGROUND

  • Marzook HAM, Abdel Razek AA, Yousef EA, Attia AAMM. Intra-articular injection of a mixture of hyaluronic acid and corticosteroid versus arthrocentesis in TMJ internal derangement. J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):30-34. doi: 10.1016/j.jormas.2019.05.003. Epub 2019 May 20.

    PMID: 31121331BACKGROUND

  • AbdulRazzak NJ, Sadiq JA, Jiboon AT. Arthrocentesis versus glucocorticosteroid injection for internal derangement of temporomandibular joint. Oral Maxillofac Surg. 2021 Jun;25(2):191-197. doi: 10.1007/s10006-020-00901-3. Epub 2020 Sep 1.

    PMID: 32870434BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

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
SPONSOR INVESTIGATOR
PI Title
Demonstrator at the Department of oral and Maxillofacial Surgery

Study Record Dates

First Submitted

November 10, 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

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR

Locations

EG(1)