Accuracy of Patient Specific Guide for TMJ Injection
Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.
1 other identifier
interventional
5
1 country
1
Brief Summary
This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
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
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2022
CompletedFirst Submitted
Initial submission to the registry
August 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedAugust 30, 2022
August 1, 2022
4 months
August 26, 2022
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Angle of deviation
The angle (°) between the planned and actual needle measured.
1 month
Vertical displacement of needle tip
The vertical displacement of the actual needle tip in comparison to the planned one (mm).
1 month
Overall needle tip dislocation
The distance between the planned and actual needle tips (mm).
1 month
Study Arms (1)
Patient specific guided injection
EXPERIMENTALPatients treated with HA injection in TMJ using PSG and the accuracy evaluated using MSCT.
Interventions
Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Patients who would not respond to conservative treatment as the first line of treatment.
You may not qualify if:
- Lactating, pregnant or planning pregnancy women.
- Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Al-Azhar University.
Cairo, 11884, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
AbdElKader A Hyder, MSc
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
- STUDY DIRECTOR
Wael A ElMohandes, PhD
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
- STUDY DIRECTOR
Bahaa El-Din A Tawfik, PhD
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 26, 2022
First Posted
August 30, 2022
Study Start
April 19, 2022
Primary Completion
August 3, 2022
Study Completion
August 22, 2022
Last Updated
August 30, 2022
Record last verified: 2022-08