Patient Satisfaction in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-40 years old

Complete dentition.

Normal jaw opening.

Intact teeth.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Occlusal splints manufactured with fully digital workflow.

    Device

    The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device. The acquisition and scanning of the patients are done by using an intra oral scanner and designing them using a designing software. This device will be printed with a 3D printer utilizing printable resin material

  • Occlusal splints manufactured with Conventional workflow

    Device

    For the comparator group, maxillary and mandibular impressions will be made with Cavex CA37 alginate impression material (Cavex Holland B.V, Holland), models will be poured with gypsum (Kimberlit, Type IV Dental Stone, Protechno Spain), facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator (Bio-art, A7Plus, Brazil), wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Occlusal splints manufactured with Conventional workflowActive comparator 1 intervention
Group B: Occlusal splints manufactured with fully digital workflowExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient satisfaction

Primary outcome: patient satisfaction will be recorded using Numeric scales (TMD/NS, 10 cm), this questionnaire includes the following aspects; headaches, face pain, jaw joint pain, jaw joint noises, mastication pain, neck pain, face tension, limitation of mouth opening, complaints during mastication, and teeth sensitivity at baseline and then after 1 and 3 months. The questioner was translated into Arabic language to be understood by the patients.

Time frame
'' Up to 12 weeks''

Secondary outcomes

1

Amount of occlusal adjustments

Secondary outcome: amount occlusal adjustments (representing 3-dimensional volumetric changes). After finishing of occlusal device, it will be scanned with the scanner (pre-adjustment scan). The scanning will be repeated after adjustment of the occlusal device by the clinician (post-adjustment scan). The STL files of both the pre and post adjustments scans for each occlusal device will be imported to Medit link and the two scans will be superimposed by the "best fit alignment" and "3D compare" functions will be carried out to measure the amount of intraoral occlusal adjustments (in mm) that was performed

Time frame
Base line or day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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