NCT06694532

Brief Summary

The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

October 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

October 30, 2023

Last Update Submit

November 15, 2024

Conditions

Temporomandibular Joint DisordersArthrocentesis

Outcome Measures

Primary Outcomes (1)

  • EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis

    The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder. , 1- significantly improving the pain on scale 1-10 , and

    36 months

Secondary Outcomes (1)

  • comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis

    36 months

Study Arms (2)

high molucular weight hyalurinic acid .

EXPERIMENTAL

patients injected e high molucular weight hyalurinic acid .

Drug: Hyaluronic acidDevice: Syringes

low molcular weight hyaurinic acid

EXPERIMENTAL

patients injected with low molucular weight hyalurinic acid .

Drug: Hyaluronic acidDevice: Syringes

Interventions

Hyaluronic acidDRUG

Comparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device

Also known as: Arthrocentesis
high molucular weight hyalurinic acid .low molcular weight hyaurinic acid
SyringesDEVICE

Whilst you are asleep, two small needles will be inserted into the TMJ / Jaw Joint. One of these needles allows sterile saline to be pumped into the joint under pressure whilst the other needle allows the saline to drain out of the joint then injection of the HA injectiable products .

Also known as: Arthrocentesis
high molucular weight hyalurinic acid .low molcular weight hyaurinic acid

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain or tenderness of the jaw
  • Pain in one or both of the temporomandibular joints
  • Aching pain in and around your ear
  • Difficulty chewing or pain while chewing
  • Aching facial pain
  • Locking of the joint,

You may not qualify if:

  • Muscular TMJ disorders
  • Bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Univeristy

Asyut, 12346, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Hyaluronic AcidArthrocentesisSyringes

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesEquipment and Supplies

Study Officials

  • Basel K Mohamed

    Assiut Univeristy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Basel K Mohamed

CONTACT

+201099848089Basel_shrider@yahoo.com

Basel K Mohamed

CONTACT

+201099848089

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment, were included in the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 19, 2024

Study Start

October 31, 2023

Primary Completion

February 1, 2026

Study Completion

February 28, 2026

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)