NCT07356622

Brief Summary

This clinical study evaluated digital occlusal recording methods used in the fabrication of Michigan occlusal splints. The objective was to assess whether different digital bite registration techniques influenced the accuracy of occlusal splints and the amount of occlusal adjustment required at clinical fitting. Participants underwent digital bite registration procedures and received Michigan occlusal splints fabricated using different digital workflows. Follow-up visits were conducted for splint fitting and occlusal assessment. Participant safety and data confidentiality were maintained throughout the study, and all required ethical approvals and risk assessments were obtained prior to study initiation. The study findings were intended to support improvements in digital dental workflows and enhance the accuracy and efficiency of occlusal splint fabrication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 5, 2026

Last Update Submit

January 23, 2026

Conditions

Temporomandibular Disorders (TMD)

Keywords

Digital occlusal recordingDigital bite registrationOcclusal splint fabricationOcclusal splint accuracyMichigan splintDigital facebowVirtual articulatorThree-dimensional printing

Outcome Measures

Primary Outcomes (1)

  • Volumetric occlusal adjustment of michigan occlusal splints

    The primary outcome was the volume of occlusal adjustment required for Michigan occlusal splints fabricated using different digital bite registration workflows. Volumetric changes were quantified by calculating root mean square (RMS) deviation values between pre-adjustment and post-adjustment digital scans of each splint using three-dimensional surface comparison software. Higher RMS values indicated greater occlusal adjustment.

    Baseline (pre-adjustment) and at splint fitting (post-adjustment)

Secondary Outcomes (1)

  • Occlusal contact quality after adjustment of michigan occlusal splints

    At splint fitting visit

Other Outcomes (1)

  • Pattern of occlusal adjustment on splints after fitting

    Baseline (before adjustment) and at splint fitting

Study Arms (4)

Retruded axis position(RAP with) without a digital facebow

EXPERIMENTAL

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including Retruded axis position(RAP with) without a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

Device: Digital face-bow, digital bite registration, digital scanning

Retruded axis position(RAP) with a digital facebow.

EXPERIMENTAL

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including Retruded axis position(RAP) with a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

Device: Digital facebow, digital bite registration, digital scanning

Intercuspal position (ICP) with a digital facebow

EXPERIMENTAL

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including maximum intercuspal position (ICP) with a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

Device: Retruded axis position(RAP with) without a digital facebow

Intercuspal position (ICP) without a digital facebow.

EXPERIMENTAL

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including maximum intercuspal position (ICP) without a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

Device: Digital face-bow, digital bite registration, digital scanning

Interventions

Retruded axis position(RAP with) without a digital facebowDEVICE

The intervention involves the fabrication of Michigan occlusal splints using different digital bite registration workflows. Each participant undergoes digital occlusal recording in centric relation (CR) and intercuspal position (ICP), with and without the use of an Axioprisa® digital facebow, and articulation is performed using Axioprisa® virtual articulator. Four splints are fabricated per participant based on these recordings. Participants are blinded to the recording method used for each splint and try all splints in a crossover manner. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

Intercuspal position (ICP) with a digital facebow
Digital facebow, digital bite registration, digital scanningDEVICE

The intervention involves the fabrication of Michigan occlusal splints using different digital bite registration workflows. Each participant undergoes digital occlusal recording in centric relation (CR) and intercuspal position (ICP), with and without the use of an Axioprisa® digital facebow, and articulation is performed using Axioprisa® virtual articulator. Four splints are fabricated per participant based on these recordings. Participants are blinded to the recording method used for each splint and try all splints in a crossover manner. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

Retruded axis position(RAP) with a digital facebow.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65.
  • Able to provide informed consent.
  • Have no more than one tooth missing per quadrant.

You may not qualify if:

  • Patients with removable dentures
  • Patients receiving medication for psychological disorders.
  • Patients diagnosed with systemic joint disorders.
  • Pregnant.
  • Patients who have received TMD treatment in the last 6 months.
  • Deep bite cases.
  • Those who have an extreme class 3 dental or skeletal relationship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, Sothwarck, SE1 9RT, United Kingdom

Location

Related Publications (2)

  • Obrez A, et al. Accuracy of opening the vertical dimension on virtual articulators. J Prosthodont. 2019.

    BACKGROUND

  • 1-Gross MD. The facebow: Use, misuse, and abuse. J Prosthet Dent. 1982;48:377-382.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded to the type of digital bite registration method used to fabricate each of the four Michigan occlusal splints. Each participant is required to try four splints in a crossover manner, with splints coded and presented in identical appearance so that participants cannot distinguish which recording method was used for any given splint. Clinicians and researchers involved in splint fabrication and assessment are not blinded.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Participants undergo multiple digital bite registration procedures. Michigan occlusal splints fabricated using each method are assessed within the same participant, allowing within-subject comparison of occlusal accuracy and root mean square (RMS) deviation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Arwa Ibrahim Alhusban

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 21, 2026

Study Start

March 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the small sample size and the potentially identifiable nature of dental imaging and 3D surface data. Aggregate, anonymised results will be reported.

Locations

GB(1)