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

NCT06985173 | Not Yet Recruiting DMC

• 1 other identifier: PROSR 3-3-32025
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Conditions

Temporomandibular Joint Disorders

Outcome Measures

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.

  '' Up to 12 weeks''

Secondary Outcomes (1)

• Amount of occlusal adjustments

  Base line or day 1

Study Arms (2)

Occlusal splints manufactured with Conventional workflow

ACTIVE COMPARATOR

For the comparator group, maxillary and mandibular impressions will be made with alginate impression material, models will be poured with gypsum, 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, wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint

Device: Occlusal splints manufactured with Conventional workflow

Occlusal splints manufactured with fully digital workflow

EXPERIMENTAL

The intervention involves the fabrication of 3D printing of 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

Device: Occlusal splints manufactured with fully digital workflow.

Interventions

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 fully digital workflow

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

Occlusal splints manufactured with Conventional workflow

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Hadeer Hadi

CONTACT

+201025013956; Hadeer.Abdelhadi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 22, 2025
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share