Comparison Between Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock

NCT ID: NCT06473376

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2023-12-30

Brief Summary

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This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.

Detailed Description

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This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders. The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes.

Conditions

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TMJ Disorder TMJ Disc Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I (Control)

Hegab TMJ splint

Group Type OTHER

arthrocentesis

Intervention Type PROCEDURE

TMJ arthrocentesis and arthroscopy

Group II

arthrocentesis

Group Type OTHER

arthrocentesis

Intervention Type PROCEDURE

TMJ arthrocentesis and arthroscopy

GROUP III

arthroscopy

Group Type OTHER

arthrocentesis

Intervention Type PROCEDURE

TMJ arthrocentesis and arthroscopy

Interventions

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arthrocentesis

TMJ arthrocentesis and arthroscopy

Intervention Type PROCEDURE

Other Intervention Names

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arthroscopy

Eligibility Criteria

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Inclusion Criteria

* Patients with TMJ closed lock confirmed

Exclusion Criteria

* rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Hegab

Prof. Ayman Hegab

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar UNIVERSITY

Cairo, , Egypt

Site Status

Prof.Hegab

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AUAREC20200503-8

Identifier Type: -

Identifier Source: org_study_id

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