NCT07239037

Brief Summary

Background: Millions of individuals worldwide suffer from temporomandibular joint (TMJ) disorders and are characterized by pain and joint dysfunction. TMJ internal derangement (ID) is the most frequent type of temporomandibular disorders (TMDs). TMJ arthrocentesis represents a form of minimally invasive surgical treatment in patients suffering from internal derangement of the TMJ Aim of the study: To clinically compare between the effect of TMJ arthrocentesis under high hydraulic pressure by dental implant motor and the conventional method in treatment of TMJ internal derangement regarding pain and mandibular movements.

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 2024

Shorter than P25 for not_applicable

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

October 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in pain scores

    a 10 point visual analogue scale (VAS)\*. (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe) .

    1 week, 4 weeks, 3 months

  • Change in mouth opening

    The patient's maximum mouth opening (MMO) value will be measured by taking the average of three consecutive measurements of the distance between the maxilla and mandible mid-central incisive teeth with the Endo ruler after the patients were asked to open

    baseline, 1 week, 4 weeks, 3 months

Secondary Outcomes (2)

  • post operative edema

    1 week

  • change in mandibular movements

    baseline, 1 week, 3 months

Study Arms (3)

implant motor irrigation I

EXPERIMENTAL
Other: Motor irrigation with 80% power

implant motor irrigation II

EXPERIMENTAL
Other: Motor irrigation with 40% power

Conventional arthrocentesis

ACTIVE COMPARATOR
Other: conventional TMJ arthrocentesis

Interventions

ten patients with TMJ internal derangement with reduction using dental implant motor irrigation pump in power 80%

implant motor irrigation I

ten patients with TMJ internal derangement with reduction using dental implant motor irrigation pump in power 40%

implant motor irrigation II

ten patients with TMJ internal derangement using conventional technique

Conventional arthrocentesis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • TMJ internal derangement with reduction.
  • Both genders.

You may not qualify if:

  • Patients with overlying infection or cellulitis
  • Relevant systemic disease
  • Previous TMJ surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

October 1, 2024

Primary Completion

July 15, 2025

Study Completion

July 15, 2025

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations