NCT07463404

Brief Summary

Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement

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 phase_3

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 5, 2026

Last Update Submit

March 13, 2026

Conditions

Temporomandibular Joint Internal Derangement

Keywords

temporomandibular joint internal derangementReducing discomfortrestoring normal mandibular motionsenhancing patients' quality of life

Outcome Measures

Primary Outcomes (3)

  • Mandibular Movements: measured in millimeters using a ruler or digital caliper.

    Mandibular Movements: Including maximum mouth opening (MMO), right and left lateral movements, and protrusive movement, measured in millimeters using a ruler or digital caliper.

    immediately, one, three and six months postoperatively

  • pain assessed by visual analogue scale

    Pain: Assessed using a Visual Analogue Scale ranging from 0 to 10 over the TMJ area \[ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain\].

    preoperatively, one, three and six months postoperatively

  • Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.

    Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.

    immediately, one, three, six months postoperatively

Study Arms (2)

patients with anterior disc displacement with reduction

ACTIVE COMPARATOR

10 cases with anterior disc displacement with reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).

Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis

patients with anterior disc displacement without reduction

ACTIVE COMPARATOR

10 cases with anterior disc displacement without reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).

Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis

Interventions

Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesisCOMBINATION_PRODUCT

Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis

patients with anterior disc displacement with reductionpatients with anterior disc displacement without reduction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged from 18 to 40 years old.
  • patients diagnosed with ID of TMJ, suffering from limited mandibular movements, joint pain and clicking.
  • Patients who are free from any systemic disease and controlled systemic disease (ASA I) (ASA II).
  • Patients willing to comply with the follow-up schedule and treatment protocol.
  • both genders are included

You may not qualify if:

  • Patients with systemic diseases (ASA III, IV, V).
  • Patients who have myofascial pain dysfunction syndrome only.
  • Patients who have previous surgery in TMJ.
  • Patients who have previous arthrocentesis within 1 year.
  • Patients who received previous trauma to the joint.
  • Use of anticoagulants or immunosuppressive medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry Suez Canal university

Ismailia, Egypt

Location

Study Officials

  • hossni elshahat hossni, postgraduate student

    Suez Canal University

    PRINCIPAL INVESTIGATOR

  • Suez Canal University

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was conducted on adults between the age of 18-40 years old with temporomandibular joint internal derangement (20 cases) requiring arthrocentesis, the patients were divided to 10 cases with anterior disc displacement with reduction and 10 cases with anterior disc displacement without reduction, and the two groups will be injected after arthrocentesis by combination of PRP and Cyclooxygenase Enzyme-2 Inhibitor.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 11, 2026

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

November 25, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

it is secret to patient

Locations

EG(1)