Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132594
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-07
Brief Title:
Computed Guided Prolotherapy Versus Conventional Prolotherapy
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Computed Guided Prolotherapy Versus Conventional Prolotherapy in Treatment of TMJ Internal Derangment
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint TMJ internal derangement
Detailed Description:
This study will include patients with TMJ internal derangement with signs and symptoms of pain clicking and limited mouth opening The study will be held in oral and maxillofacial department Faculty of Dental Medicine Al-Azhar University Assiut branch Internal derangement of the joint will be confirmed by magnetic resonance image MRI
Patients included in this study will be divided randomly into two equal groups by the aid of financial coins Group I patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45 angle on the dental chair with the head turned toward the unaffected side The target site will be prepared and disinfected with betadine The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line
Group II patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide which will lead the needle insertion and the accuracy of the needle insertion into the superior space of the TMJ will be assessed
Preparation of I-PRF
The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes vaccutainers under aseptic conditions The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group
Patients included in this study will be divided randomly into two equal groups by the aid of financial coins Group I patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45 angle on the dental chair with the head turned toward the unaffected side The target site will be prepared and disinfected with betadine The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line
Group II patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide which will lead the needle insertion and the accuracy of the needle insertion into the superior space of the TMJ will be assessed
Preparation of I-PRF
The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes vaccutainers under aseptic conditions The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None