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Temporomandibular Disorders (TMD)AVOAMSDBRNCT07356622

Occlusal Adjustments Needed for Michigan Splints Made Using Different Digital Bite Records

A study testing Retruded axis position(RAP with) without a digital facebow, Digital face-bow, digital bite registration, digital scanning and Digital facebow, digital bite registration, digital scanning in people with Temporomandibular Disorders (TMD), run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorders (TMD)
What is being tested?
Retruded axis position(RAP with) without a digital facebow, Digital face-bow, digital bite registration, digital scanning and Digital facebow, digital bite registration, digital scanning
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
1 Mar 2024to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • King's College London

    London, Sothwarck, SE1 9RT

Other trials in United Kingdom

About this study

Official title: The Assessment of The Volumetric Occlusal Adjustments Required for Michigan Splints Fabricated Using Various Digital Bite Registrations

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.

Read the detailed description

Background Temporomandibular disorders represented a common clinical condition affecting mandibular function and were frequently associated with parafunctional activities such as bruxism or clenching. Clinical features included orofacial pain, joint sounds, restricted mandibular movement, headaches, dental wear, and occlusal instability. Occlusal splints were commonly prescribed to reduce occlusal loading, protect dental structures, and establish a more favourable mandibular position.

Conventional occlusal splint fabrication relied on physical impressions, mechanical articulation, and manual occlusal adjustment. These processes were time-consuming and technique-sensitive. Digital dentistry introduced alternative workflows incorporating intraoral scanning, virtual articulation, and computer-aided design and manufacturing, with the aim of improving accuracy, reproducibility, and efficiency.

Accurate digital recording of the maxillomandibular relationship remained a critical factor influencing occlusal outcomes. Digital bite registration techniques performed at intercuspal position or centric relation, with or without digital facebow transfer, were expected to affect occlusal accuracy and the extent of chairside adjustment required at delivery.

Virtual articulators were developed to simulate mandibular movements using digitally acquired data. These systems required accurate digital impressions, occlusal records, and appropriate orientation of the maxillary arch relative to craniofacial reference planes. Digital facebow systems enabled virtual transfer of maxillary position and were expected to improve mounting accuracy compared with average-value articulators alone.

Study objectives Primary Objectives

  • To evaluate volumetric changes on the occlusal surfaces of Michigan splints following clinical adjustment.
  • To compare pre-adjustment and post-adjustment occlusal surface volumes across different digital workflows.
  • To assess whether an average-value virtual articulator produced occlusal splints at an increased occlusal vertical dimension without the need for clinical registration.

Secondary objectives

  • To assess laboratory efficiency and quality control associated with digital workflows.
  • To evaluate clinical time and effort required for occlusal adjustment.
  • To assess participant comfort during digital recording procedures.

This was a single-centre clinical study involving 10 participants. Each participant received four Michigan occlusal splints, corresponding to four different digital design workflows based on mandibular recording position and the inclusion or exclusion of a digital facebow record. Each of the four digital designs generated for every participant was manufactured as a separate occlusal splint, resulting in four splints per participant.

Clinical and laboratory procedures Visit 1

  • Informed consent was obtained.
  • Standardised dental photography was performed.
  • A digital facebow record was obtained using a digital facebow system equipped with a scannable bite fork (Axiopresia) as part of the registration process, where applicable. The scannable bite fork was positioned intraorally and digitally captured to record the spatial relationship of the maxillary arch relative to craniofacial reference planes.
  • Digital impressions of the maxillary and mandibular arches were obtained using an intraoral scanner under standardised clinical conditions.
  • Bite registration at centric relation/ retruded articulation position was obtained following neuromuscular deprogramming using a Lucia gauge and intraoral scanner.
  • Bite registration at intercuspal position was recorded using the intraoral scanner.

Laboratory procedures

Using computer-aided design software, four distinct digital occlusal splint designs were produced for each participant based on different combinations of mandibular recording position and digital facebow transfer:

Retruded articulation position (centric relation) with digital facebow record Retruded articulation position (centric relation) without digital facebow record Intercuspal position with digital facebow record Intercuspal position without digital facebow record Each digital design was generated using the same virtual articulator parameters and identical splint design settings, differing only in the mandibular position record and the inclusion or exclusion of the digital facebow data. The resulting designs were then manufactured using three-dimensional printing.

Visit 2: Fitting and occlusal adjustment

  • Clinical fitting of the occlusal splints was performed during the second visit.
  • Occlusal adjustments were carried out to achieve balanced light occlusal contacts at the resting intercuspal position.
  • Lateral movements were assessed to confirm canine guidance, and anterior guidance was evaluated during protrusive movements.
  • Any occlusal interferences were identified and removed accordingly to achieve a stable and harmonious occlusal scheme.
  • Following completion of occlusal adjustments, the splints were digitally scanned via lab scanner for post-adjustment analysis.

Outcome assessment Pre-adjustment and post-adjustment digital scans of each occlusal splint were imported into three-dimensional analysis software ( Geomagic software). Root mean square deviation values were calculated following best-fit alignment to quantify volumetric changes associated with occlusal adjustment. The 3D and 2D Comparisons at six sections were done ( middle of the cingulum of the right and left central incisor, middle of the cingulum of the right and left canines, messy-buccal cusp to disco-palatal cup of the right and left first molar). Occlusal deviation maps were standardised using consistent colour scales to allow comparison between workflows.

Being tested
Retruded axis position(RAP with) without a digital facebow, Digital face-bow, digital bite registration, digital scanning, Digital facebow, digital bite registration, digital scanning
Keywords
Digital occlusal recording, Digital bite registration, Occlusal splint fabrication, Occlusal splint accuracy, Michigan splint, Digital facebow, Virtual articulator, Three-dimensional printing
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Digital face-bow, 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.

  • 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.

Study groups in NCT07356622
Study groupRoleWhat they receive
Retruded axis position(RAP with) without a digital facebowExperimentalEach 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.
Receives: Device: Digital face-bow, digital bite registration, digital scanning
Retruded axis position(RAP) with a digital facebow.ExperimentalEach 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.
Receives: Device: Digital facebow, digital bite registration, digital scanning
Intercuspal position (ICP) with a digital facebowExperimentalEach 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.
Receives: Device: Retruded axis position(RAP with) without a digital facebow
Intercuspal position (ICP) without a digital facebow.ExperimentalEach 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.
Receives: Device: Digital face-bow, digital bite registration, digital scanning

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Occlusal contact quality after adjustment of michigan occlusal splints

    The secondary outcome was the qualitative assessment of occlusal contact quality following clinical adjustment of Michigan occlusal splints fabricated using different digital workflows. Occlusion was assessed clinically to confirm balanced light contacts at the resting intercuspal position, presence of canine guidance during lateral excursions, presence of anterior guidance during protrusive movements, and elimination of occlusal interferences. Outcomes were recorded as achievement of a stable and clinically acceptable occlusal scheme following adjustment.

    Measured: At splint fitting visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start1 Mar 2024
  3. Primary completion1 Dec 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356622
Sponsor's protocol ID
43439
Other IDs
HR2301469
Acronym
AVOAMSDBR
Status last verified
Jan 2026
First submitted
5 Jan 2026
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Retruded axis position(RAP with) without a digital facebow, Digital face-bow, digital bite registration, digital scanning and Digital facebow, digital bite registration, digital scanning in people with Temporomandibular Disorders (TMD), run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volumetric occlusal adjustment of michigan occlusal splints (time frame: Baseline (pre-adjustment) and at splint fitting (post-adjustment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07356622, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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