Comparison Between Hegab Splint, Arthrocentesis, and Arth... | NCT06473376

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

NCT06473376

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Jun 25, 2024Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

TMJ Disorder
TMJ Disc Disorder

Interventions

arthrocentesis

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2020Actual

Primary Completion Date

Jul 30, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Jun 18, 2024

First Submission Date that Met QC Criteria

Jun 23, 2024

First Posted Date

Jun 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2024

Last Update Posted Date

Jun 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I (Control)	Other	Hegab TMJ splint	Procedure: arthrocentesis
Group II	Other	arthrocentesis	Procedure: arthrocentesis
GROUP III	Other	arthroscopy	Procedure: arthrocentesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
arthrocentesis	Procedure	TMJ arthrocentesis and arthroscopy	GROUP III Group I (Control) Group II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in pain using a visual analog scale,	The primary outcome variable was the change in pain using a visual analog scale (VAS), with 0 indicating the absence of pain and 10 indicating the worst pain possible	one year
improvement of maximum voluntary mouth opening	improvement of maximum voluntary (non-assisted) mouth opening (MVMO) in millimetres.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with TMJ closed lock confirmed

Exclusion Criteria:

rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar UNIVERSITY		Cairo			Egypt
Prof.Hegab

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069237	Arthrocentesis
D001182	Arthroscopy

Ancestor Terms

ID	Term
D019152	Paracentesis
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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