Clinical trial NCT06985173: Patient Satisfaction in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow
Official title: Patient Satisfaction and Occlusal Adjustments in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow in TMD Patients. (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic) utilizing printable resin material.
Primary purpose: TREATMENT

Brief summary: According to published literatures, the prevalence of TMD is approximately 10% in patients over 18 years of age with a considerable proportion being women of reproductive age. The treatment of TMD presents the following goals: decreasing joint and masticatory muscle pain, increasing the range of motion in the mandible, preventing degenerative changes in the articulating tissues. Management of TMD can be either conservative or surgical treatments, the conservative treatments include analgesia, medications, physical therapy, occlusal adjustment, splint therapy, localized steam application, and external muscle massage. The occlusal splint therapy is considered a common treatment option for TMD management. Flat stabilization splint is the preferred splint for such cases. It is designed to promote occlusal stability and decrease muscles tension by altering occlusion and allowing complete seating of the condyle in centric relation.

The evolution of digital technology created new era of dentistry that successfully digitalized the traditional workflow of occlusal splints including designing and manufacturing. Furthermore, virtual facebow and dynamic jaw relation record using jaw tracking device are another digital reward. The digital workflow can offer more predictable approach for occlusal splint construction, It could eliminate the traditional technical errors and enhance the occlusal accuracy

Detailed description: The traditional workflow of occlusal splints includes, primary impression for both arches, pouring casts, patient deprogramming and centric jaw relation record followed by mounting. Then the occlusal splint is made out of a resin that includes wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint. After that, it is trimmed, polished, and seated back on the duplicate of the invested casts. It is a complicated process and time- consuming constructed followed by occlusal adjustments on the articulator. That traditional approach is time consuming and prone to many technical errors. Such errors are reflected in occlusal discrepancies that are considered critical for the effectiveness of occlusal splint therapy.

Recent advancements in the field of intra-oral scanning (IOS), jaw tracking device for digitally recording the maxillomandibular relationship, maximum intercuspation, centric occlusion and the patient's mandibular motion. This technique incorporates the mandibular motion into the 3-dimensional (3D) virtual patient representation to integrate the 3D dynamic virtual patient visualization and computer-aided design/computer-aided manufacturing (CAD/CAM) may have the potential to compensate for some of the shortcomings of conventional splint therapy and deliver improved clinical results, while simplifying the workflow. Several studies have shown the improved quality and material properties of CAD/CAM splints in comparison to conventional ones, but little of them reported fully digital workflow starting from scanning of maxillary and mandibular teeth, using jaw tracking device to obtain personalized condylar motion parameters and individualized maxillary position to better simulate the actual movement of the patient in the laboratory (Revilla, Marta etal,2022) and Computer-aided design/computer-aided manufacturing (CAD/CAM) in final production of occlusal splints all of these fully digital steps may be possibly reducing the adjustment time for occlusal devices and achieving predictable efficacy.

This study aims to compare the difference, if present in patient satisfaction and the amount of occlusal adjustments in occlusal splints fabricated using fully digital versus conventional workflow.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old
* Complete dentition.
* Normal jaw opening.
* Intact teeth.
* No ongoing dental therapy, such as orthodontic or prosthodontic treatment.
* TMD patients with more than one of following symptoms or signs: myofascial pain and /or pain in the TMJ, myofascial pain and/or pain in the TMJ on palpation, muscles tenderness, headache or earache.
* Patients who had unsuccessfully undergone splint therapy or other TMD treatments in the past were not excluded.

Exclusion Criteria:

* Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, osteoporosis, and patients taking analgesic, muscle relaxant, or anti inflammatory drugs were excluded because such drugs could influence the results.
* Temporomandibular joint lesions found on clinical palpation or medical imaging examination.
* Jaw opening less than 3 fingers.
* Patients with occlusal dysfunctions.
* Patients with severe or moderate periodontitis.
* Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.

Primary outcomes:
measure: Patient satisfaction
timeFrame: '' Up to 12 weeks''
Secondary outcomes:
measure: Amount of occlusal adjustments
timeFrame: Base line or day 1
Other outcomes:
Locations:
Study officials:
References: