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.
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.
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.
- Conditions
- Temporomandibular Disorders (TMD)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. 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.
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)
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.
- First posted21 Jan 2026
- Study start1 Mar 2024
- Primary completion1 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's Hospital
- Responsible party
- Principal investigator, Arwa Alhusban, King's College London
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of The Volumetric Occlusal Adjustments Required for Michigan Splints Fabricated Using Various Digital Bite Registrations
- ClinicalTrials.gov ID
- NCT07356622
- Acronym / sponsor ID
- AVOAMSDBR / 43439
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Digital occlusal recording, Digital bite registration, Occlusal splint fabrication, Occlusal splint accuracy, Michigan splint, Digital facebow, Virtual articulator, Three-dimensional printing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Retruded axis position(RAP with) without a digital facebow | Experimental | Device: Digital face-bow, digital bite registration, digital scanningEach 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. |
| Retruded axis position(RAP) with a digital facebow. | Experimental | Device: Digital facebow, digital bite registration, digital scanningEach 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. |
| Intercuspal position (ICP) with a digital facebow | Experimental | Device: Retruded axis position(RAP with) without a digital facebowEach 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. |
| Intercuspal position (ICP) without a digital facebow. | Experimental | Device: Digital face-bow, digital bite registration, digital scanningEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65.
- Able to provide informed consent.
- Have no more than one tooth missing per quadrant.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retruded axis position(RAP with) without a digital facebowThe 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. | Device | Intercuspal position (ICP) with a digital facebow |
| Digital face-bow, digital bite registration, digital scanningThe 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. | Device | Intercuspal position (ICP) without a digital facebow., Retruded axis position(RAP with) without a digital facebow |
| Digital facebow, digital bite registration, digital scanningThe 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. | Device | Retruded axis position(RAP) with a digital facebow. |
Primary outcome
Volumetric occlusal adjustment of michigan occlusal splints
Time frame: Baseline (pre-adjustment) and at splint fitting (post-adjustment)
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.
1 secondary outcome
Occlusal contact quality after adjustment of michigan occlusal splints
Time frame: At splint fitting visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- BackgroundObrez A, et al. Accuracy of opening the vertical dimension on virtual articulators. J Prosthodont. 2019.
- Background1-Gross MD. The facebow: Use, misuse, and abuse. J Prosthet Dent. 1982;48:377-382.
- Clinical trial ethics websuteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.