Clinical Evaluation of Occlusal Stabilization Splints Fabricated Using Conventional Versus Fully Digital Workflow

NCT ID: NCT07074340

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-03-30

Brief Summary

Temporomandibular disorders (TMDs) are considered one of the most common diseases in the dental clinic. TMDs are considered a major cause of chronic orofacial pain that affects the patient's daily activities and jaw function.

Occlusal splints are the most commonly used treatment modality for TMDs because of their low cost, ease of use and broad indications. Traditional workflow is complicated, technique sensitive and time-consuming as more chair-side time is required for occlusal adjustments . Recently, the revolutionary advances in digital technology have been widely used in prosthodontics, including the use of scanners, jaw tracking devices and CAD-CAM technologies. The fully digital workflow can offer more accuracy and less time consumption . However, literature is still limited and inconclusive regarding the use of fully digital workflows for occlusal splint construction.

Detailed Description

Stabilization splints (SS) are a major type of occlusal splints that is constructed from hard acrylic and designed to fully cover the maxillary and mandibular dentition in centric occlusion. They provide the patient with a stable occlusion in which the maximum number of simultaneous occlusal contacts, allows an adaptation of the TMJ apparatus and aids in self-repositioning of the condyle in the glenoid fossa.

Conventionally, the occlusal stabilization splint is made by fabrication a wax pattern on surveyed and mounted casts in centric relation then it is processed using lost wax technique to form a clear, heated-cured acrylic resin splint. The splints are thereafter tried intraorally and adjusted to obtain the desired adaptation to the teeth. The process of centric relation registration is complicated, technique sensitive and time- consuming. In addition, the conventional acrylic processing impairs the splint efficacy because of the presence of high porosity, high residual monomer content and shrinkage that affect the dimensional stability and accuracy.

Digital technology in prosthodontics has made revolutionary changes. The use of scanners, jaw tracking devices and CAD-CAM technologies has been involved widely regarding designing and manufacturing. This type of technology has demonstrated greater benefits in terms of dimensional stability, speed, better retention, and greater reproducibility. A study found that construction digitally printed stabilization splints with the use of intra-oral scanner and CAD-CAM showed the same patient improvement when compared to traditional workflow but with significant decrease in the required chairside time. Another concluded that the digital workflow was significantly preferred method among the participants during the construction of stabilization splints.

Recently, digital face bows and jaw tracking devices have been widely used used to record the mandibular movement and the jaw relationship for the fabrication of occlusal devices. These recent digital technologies can reduce the traditional errors and production time present in the conventional method of data acquisition for splints construction, which could improve the accuracy of occlusal splints and decrease the amount of intraoral occlusal adjustments that need to be made. There is a lack in the clinical trials investigating the use of jaw tracking device to acquire personalized articulator parameters to guide the production of occlusal stabilization splints. Hence, this clinical trial is aiming to compare chair side time and treatment outcomes (pain intensity and jaw functional limitation) of stabilization splints fabricated through a fully digital workflow using jaw tracking device for mandibular movement registration versus conventional workflow in patients with (TMDs).

Conditions

Tempromandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Occlusal Splints manufactured with Conventional workflow

maxillary and mandibular impressions will be made using rubber base impression material and the bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. The occlusal record will be supplemented with a facebow transfer on a semi-adjustable articulator. The stabilization splint will be designed as wax-up then transferred to a duplicate cast for processing into heat-cured acrylic. After processing, the splint will be replaced on the master cast for occlusion refinement

Group Type: ACTIVE_COMPARATOR

occlusal stabilization splint manufactured with a conventional workflow

Intervention Type: DEVICE

Heat-cured acrylic resin occlusal stabilization splint

Occlusal Splints manufactured with fully-digital workflow

For the intervention group; an intraoral scanner (Medit i700, South Korea) will be used to scan the maxillary and mandibular dentition and the maxillomandibular relationship in the centric relation position. A Jaw Tracking Device (JMA analyser; Zebris, Germany) will be used to record the jaw motion of the participants. The occlusal stabilization splints will be designed using a designing software (Exocad, USA). This device will be printed with a 3D printer (Creality, China) utilizing printable resin material.

Group Type: EXPERIMENTAL

occlusal stabilization splint manufactured with Fully-digital workflow

Intervention Type: DEVICE

3D printed occlusal stabilization splints

Interventions

occlusal stabilization splint manufactured with a conventional workflow

Heat-cured acrylic resin occlusal stabilization splint

Intervention Type: DEVICE

occlusal stabilization splint manufactured with Fully-digital workflow

3D printed occlusal stabilization splints

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 20-40 years old.
• Complete dentition
• Intact and stable occlusion.
• 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

Exclusion Criteria

• Patients with severe jaw functional limitations (jaw opening less than 3 fingers).
• Patients suffering from depression, anxiety or mental disorder.
• Patients with ongoing orthodontic treatments.
• History of a recent trauma to face, head or neck.
• Presence of dento-alveolar pathology.
• Presence of sever or moderate periodontitis.
• Patients with ongoing treatment related to TMD.

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mennatallah Mohamed Moustafa

assistant lecturer at Prosthodontics department, faculty of Dentistry,Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

menna shalabi

Role: CONTACT

mennashalabii490@gmail.com

+201111860078

Other Identifiers

PROSR 3-3-12025

Identifier Type: -

Identifier Source: org_study_id