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Temporomandibular Joint DisordersNCT06132802

Evaluation of Anterior Repositioning Guided Splint Combined With or Without I Platelet-rich Fibrin

A study testing Patients who received treatment involving ARS and arthrocentesis only and Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection in people with Temporomandibular Joint Disorders, run by Mahmoud Mohammed Mahmoud Nasef at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Temporomandibular Joint Disorders
What is being tested?
Patients who received treatment involving ARS and arthrocentesis only and Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
2 Oct 2021to 14 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dental Medicine Al-Azhar University

    Asyut

Other trials in Egypt

About this study

Official title: Evaluation of Anterior Repositioning Guided Splint Combined With or Without Injectable Platelet-rich Fibrin in Treatment of TMJ Internal Derangement.

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.

Read the detailed description

The patient will be seated at a 45° angle with the head turned toward the unaffected side. After preparing and disinfecting the target site with betadine, two points will be marked over the affected joint. Local anesthesia will be administered to block the auriculotemporal nerve. Using 19-gauge needles, the superior joint space will be distended with 2-3 ml of Ringer's solution. Another needle will be inserted into the distended compartment near the articular eminence to facilitate solution flow. Lactated Ringer's solution, connected to one needle, will be infused with sufficient pressure (200 mL in 15-20 minutes) to release adhesions. Following the removal of one needle, 2 ml of injectable platelet-rich fibrin (PRF) will be injected into the superior joint space.

For the preparation of injectable PRF, 20 ml of the patient's blood will be drawn and divided into two 10 ml vaccutainers. After centrifugation, the obtained PRF will be aspirated into a 5 ml syringe, and 1.5 to 2 ml of PRF will be injected into the superior joint space.

Being tested
Patients who received treatment involving ARS and arthrocentesis only, Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection
Keywords
Anterior repositioning guided splint, Injectable platelet-rich fibrin
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients who received treatment involving ARS and arthrocentesis onlyProcedure or surgery

    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.

  • Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injectionProcedure or surgery

    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.

Study groups in NCT06132802
Study groupRoleWhat they receive
Group I: Patients who received treatment involving ARS and arthrocentesis onlyExperimentalNot described
Receives: Procedure: Patients who received treatment involving ARS and arthrocentesis only
Group II: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injectionExperimentalNot described
Receives: Procedure: Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. Pain score

    Using Visual Analogue Scale (VAS)

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

Secondary outcomes (1)

  1. Right and left lateral excursion

    In Millimeter (mm)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start2 Oct 2021
  3. Primary completion14 Oct 2022
  4. Study completion14 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132802
Sponsor's protocol ID
AUAREC20210100-07
Status last verified
Nov 2023
First submitted
10 Nov 2023
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 32433129

  • 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.

    PubMed 30963526

  • 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.

  • 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.

    PubMed 31121331

  • 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.

    PubMed 32870434

Questions about this trial

What is this clinical trial studying?

A study testing Patients who received treatment involving ARS and arthrocentesis only and Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection in people with Temporomandibular Joint Disorders, run by Mahmoud Mohammed Mahmoud Nasef at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum mouth opening (time frame: First week, first month, third months, and sixth months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06132802, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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