Computer Guided Versus Conventional TMJ Injection | NCT05288647 | Trialant

Computer Guided Versus Conventional TMJ Injection | NCT05288647 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space.	Procedure: TMJ injection
Group B	Active Comparator	Patients treated with four conventional sodium hyaluronate injections in superior TMJ space.	Procedure: TMJ injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of maximum unassisted mouth opening range	Opening range determined by asking the patient to gently open the mouth and measure the distance between upper and lower central incisor using an vernier digital electronic caliper. Vertical movement of the mandible corrected by adding the vertical overlap.	6 months
Comparison of modified Helkimo's clinical dysfunction index.	A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.	6 months
Comparison of pain intensity on Visual analog scale	Patients asked to mark their TMJ-related pain level on a scale from 0 to 10, where 0 is "no pain" and 10 is "severe pain".	6 months

Secondary Outcomes

Measure	Description	Time Frame
Total procedural time.	Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure.	Baseline
Patient convenience.	Patient convenience on a scale from "0" to "10", where "0" is highly convenient and "10" extremely intolerable.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
AbdElKader A Hyder, MSc	Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University	Principal Investigator
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 Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30940211	Background	Krause M, Dorfler HM, Kruber D, Humpfner-Hierl H, Hierl T. Template-based temporomandibular joint puncturing and access in minimally invasive TMJ surgery (MITMJS) - a technical note and first clinical results. Head Face Med. 2019 Apr 2;15(1):10. doi: 10.1186/s13005-019-0194-8.
29370321	Background	Steenks MH, Turp JC, de Wijer A. Reliability and Validity of the Diagnostic Criteria for Temporomandibular Disorders Axis I in Clinical and Research Settings: A Critical Appraisal. J Oral Facial Pain Headache. 2018 Winter;32(1):7-18. doi: 10.11607/ofph.1704.