Clinical trial NCT05288647: Computer Guided Versus Conventional TMJ Injection
Official title: Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMD
Keywords: TMD
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.

Detailed description: This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above the conventional method from the clinician and patient point of view.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with polyarthritis or degenerative joint disease.
* Patients with myofascial pain.
* Previous history of minimally invasive or invasive treatment of TMJ.
* History of mandibular fracture.
* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Primary outcomes:
measure: Comparison of maximum unassisted mouth opening range
timeFrame: 6 months
measure: Comparison of modified Helkimo's clinical dysfunction index.
timeFrame: 6 months
measure: Comparison of pain intensity on Visual analog scale
timeFrame: 6 months
Secondary outcomes:
measure: Total procedural time.
timeFrame: Baseline
measure: Patient convenience.
timeFrame: Baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Al-Azhar University.
Study officials:
affiliation: Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
name: AbdElKader A Hyder, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
name: Wael A ElMohandes, PhD
role: STUDY_DIRECTOR
affiliation: Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
name: Bahaa El-Din A Tawfik, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Rani S, Pawah S, Gola S, Bakshi M. Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional study. J Indian Prosthodont Soc. 2017 Jan-Mar;17(1):48-52. doi: 10.4103/0972-4052.194941.