Dental OcclusionNCT05471024
Occlusal Adjustment Time and Volume for Single Unit Fixed Prosthesis Fabricated With Different Virtual Mounting
A study testing Digitized Mounted Articulator Scan, Average Positioning on Virtual Bonwill Triangle and Digital Face Scan in people with Dental Occlusion and Crowns, run by Cairo University at 1 site in Egypt.
Trial summary
Regardless of the fabrication workflow occlusal adjustments seem to be inevitable during delivery of indirect fabrication of the restoration. This has been attributed to snowballing of discrepancies due to multiple procedures for information transfer between the clinician and the laboratory. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Occlusion, Crowns
- What is being tested?
- Digitized Mounted Articulator Scan, Average Positioning on Virtual Bonwill Triangle and Digital Face Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 27 Jul 2022
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged 21-70 years old, be able to read and sign the informed consent document.
- Psychologically and physically able to withstand conventional dental procedures.
- Participants with molars indicated for full coverage restorations
- Large carious lesions
- Teeth restored with large restorations
- Endodontically treated teeth
Show all 9Show fewer
- Accept to undergo face scanning and articulator mounting procedures
- Have no active periodontal or pulpal diseases, have teeth with clinically acceptable restorations.
- Able to attend punctually for preplanned visits and evaluation.
Who cannot join
- Participants with active resistant periodontal diseases.
- Participants with poor oral hygiene, high caries risk and uncooperative participants.
- Pregnant women.
- Participants in the growth stage with partially erupted teeth.
- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest.
Show all 9Show fewer
- Restored occlusal surface opposing the planned restoration.
- The presence of a removable or fixed orthodontic appliance.
- Signs of bruxism or clenching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoral Occlusal Adjustment Time and Volume Required for Single Unit Fixed Prosthesis Fabricated With Different Virtual Articulator Mounting Methods (a Randomized Controlled Clinical Trial)
Regardless of the fabrication workflow occlusal adjustments seem to be inevitable during delivery of indirect fabrication of the restoration. This has been attributed to snowballing of discrepancies due to multiple procedures for information transfer between the clinician and the laboratory. Current digital workflows minimize these discrepancies due to digital acquisition technology which eliminates drawbacks from physical materials which would alter the dimensions and morphology of the final restoration. Utilizing 3D face scanning technology is by far the least invasive and the least time consuming of available virtual facebow techniques and thus it's utilization could offer the benefit of saving time during occlusal adjustment and enhanced strength of the restoration by not subjecting it to the heat generation and subsequent crack initiation which occurs during occlusal adjustment. This study aims to compare the effect of a face scan to alignment of the maxillary cast on the volume and time of occlusal adjustment compared to conventional articulator digitization to align the maxillary cast.
Read the detailed description
This study will be carried out on participants enrolled at the outpatient fixed prosthodontics clinic, Faculty of Dentistry, Cairo University.
Digital face scanning technology has made it possible to align the maxillary cast in a virtual articulator to represent a more accurate relationship to the terminal hinge axis of the patient than average positioning on a virtual Bonwill triangle. This would be reflected on the occlusal design of the restoration and subsequently on the amount of adjustment needed to the occlusal surface of the restoration during delivery. Decreasing the amount and time of occlusal adjustment would result in a decrease in chair time, increase in the longevity of the restoration and enhanced esthetics of the restoration.
Conventional alignment and mounting of casts to simulate the patients' dynamic occlusions remains the gold standard to which newer digital cast alignment and relation technology is to be compared. Thus the selection of the articulator scan as the comparator was made
Participants' Timeline
Clinical Visit 1 Preoperative records Clinical examination, Radiographic examination, Assessment of inclusion, Informed consent, Intraoral photographs, Primary impression (irreversible hydrocolloid) for diagnostic cast fabrication.
Clinical Visit 2 Facebow record, Articulator mounting, Face Scan, Foundation restoration for participant tooth built to full contour.
Clinical Visit 3 Preparation, Impression, Provisionalisation,
Allocation Impartial third party randomly allocates jaw relation methods to participants and informs laboratory technician of allocation results.
Single unit fixed prosthesis will be fabricated as per allocation results
Clinical Visit 4 Checking and verification of restoration ensuring
- Proximal contour and contact.
- Marginal integrity
- Facial and lingual contours.
- Surface finish.
- Color and shade.
Impression prior to occlusal adjustment, Occlusal adjustment, Timing occlusal adjustment procedure, Impression after occlusal adjustment, Cementation.
- Conditions
- Dental Occlusion, Crowns
- Being tested
- Digitized Mounted Articulator Scan, Average Positioning on Virtual Bonwill Triangle, Digital Face Scan
- Keywords
- Occlusion, Occlusal Adjustment, Virtual Articulator, Occlusal Design, Occlusal Interference
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitized Mounted Articulator ScanProcedure or surgery
Conventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration.
Average Positioning on Virtual Bonwill TriangleProcedure or surgery
Virtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator.
This positioning will be utilized during design of the occlusal surface of the restoration.
Digital Face ScanProcedure or surgery
Digital face scan will be used to position the maxillary cast on the virtual articulator.
This positioning will be utilized during design of the occlusal surface of the restoration.
| Study group | Role | What they receive |
|---|---|---|
| Digitized Mounted Articulator Scan | Active comparator | Conventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator.
This positioning will be utilized during design of the occlusal surface of the restoration. Receives: Procedure: Digitized Mounted Articulator Scan |
| Average Positioning on Virtual Bonwill Triangle | Experimental | Virtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator.
This positioning will be utilized during design of the occlusal surface of the restoration. Receives: Procedure: Average Positioning on Virtual Bonwill Triangle |
| Digital Face Scan | Experimental | Digital face scan will be used to position the maxillary cast on the virtual articulator.
This positioning will be utilized during design of the occlusal surface of the restoration. Receives: Procedure: Digital Face Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Occlusal Adjustment Time
Time taken to harmonize occlusal contacts with participants masticatory function during delivery of the crown.Measured in minutes and seconds.
Measured: Immediately after verification of restoration acceptability but prior to occlusal adjustment. Time will be measured until occlusal contacts of the crown have been harmonized during the delivery clinical visit.
Secondary outcomes (1)
Volume of Occlusal Adjustment
Amount of material removed from occlusal surface of restoration to harmonize occlusal contacts during delivery of the crown with participants masticatory function.
Measured: Before and immediately after the occlusal adjustment. Volume before occlusal adjustment - volume after occlusal adjustment of the of the crown = volume difference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental OcclusionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Triple blind (participant, investigator and outcomes assessor), randomized, clinical superiority trial with 1:1:1 allocation ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aly Ayman Mohamed El-Kady, Cairo University
- Investigators
- Aly AM El-Kady, MSc, Principal investigator, Fixed Prosthodontics Department, Misr International UniversityShereen A Ameen, Prof. Dr., Study chair, Fixed Prosthodontics Department, Cairo UniversityRasha NM Sami, Prof. Dr., Study director, Fixed Prosthodontics Department, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471024
- Sponsor's protocol ID
- KADY0001
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only outcomes will be shared. Participants' personal information will be stored in a password protected folder.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoral Occlusal Adjustment Time and Volume Required for Single Unit Fixed Prosthesis Fabricated With Different Virtual Articulator Mounting Methods (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05471024
- Acronym / sponsor ID
- KADY0001
- Conditions
- Dental Occlusion, Crowns
- Keywords
- Occlusion, Occlusal Adjustment, Virtual Articulator, Occlusal Design, Occlusal Interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 22 Jul 2022 (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.
Regardless of the fabrication workflow occlusal adjustments seem to be inevitable during delivery of indirect fabrication of the restoration. This has been attributed to snowballing of discrepancies due to multiple procedures for information transfer between the clinician and the laboratory. Current digital workflows minimize these discrepancies due to digital acquisition technology which eliminates drawbacks from physical materials which would alter the dimensions and morphology of the final restoration. Utilizing 3D face scanning technology is by far the least invasive and the least time consuming of available virtual facebow techniques and thus it's utilization could offer the benefit of saving time during occlusal adjustment and enhanced strength of the restoration by not subjecting it to the heat generation and subsequent crack initiation which occurs during occlusal adjustment. This study aims to compare the effect of a face scan to alignment of the maxillary cast on the volume and time of occlusal adjustment compared to conventional articulator digitization to align the maxillary cast.
Detailed description
This study will be carried out on participants enrolled at the outpatient fixed prosthodontics clinic, Faculty of Dentistry, Cairo University.
Digital face scanning technology has made it possible to align the maxillary cast in a virtual articulator to represent a more accurate relationship to the terminal hinge axis of the patient than average positioning on a virtual Bonwill triangle. This would be reflected on the occlusal design of the restoration and subsequently on the amount of adjustment needed to the occlusal surface of the restoration during delivery. Decreasing the amount and time of occlusal adjustment would result in a decrease in chair time, increase in the longevity of the restoration and enhanced esthetics of the restoration.
Conventional alignment and mounting of casts to simulate the patients' dynamic occlusions remains the gold standard to which newer digital cast alignment and relation technology is to be compared. Thus the selection of the articulator scan as the comparator was made
Participants' Timeline
Clinical Visit 1 Preoperative records Clinical examination, Radiographic examination, Assessment of inclusion, Informed consent, Intraoral photographs, Primary impression (irreversible hydrocolloid) for diagnostic cast fabrication.
Clinical Visit 2 Facebow record, Articulator mounting, Face Scan, Foundation restoration for participant tooth built to full contour.
Clinical Visit 3 Preparation, Impression, Provisionalisation,
Allocation Impartial third party randomly allocates jaw relation methods to participants and informs laboratory technician of allocation results.
Single unit fixed prosthesis will be fabricated as per allocation results
Clinical Visit 4 Checking and verification of restoration ensuring
- Proximal contour and contact.
- Marginal integrity
- Facial and lingual contours.
- Surface finish.
- Color and shade.
Impression prior to occlusal adjustment, Occlusal adjustment, Timing occlusal adjustment procedure, Impression after occlusal adjustment, Cementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Triple blind (participant, investigator and outcomes assessor), randomized, clinical superiority trial with 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Digitized Mounted Articulator Scan | Active comparator | Procedure: Digitized Mounted Articulator ScanConventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
| Average Positioning on Virtual Bonwill Triangle | Experimental | Procedure: Average Positioning on Virtual Bonwill TriangleVirtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
| Digital Face Scan | Experimental | Procedure: Digital Face ScanDigital face scan will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be aged 21-70 years old, be able to read and sign the informed consent document.
- Psychologically and physically able to withstand conventional dental procedures.
- Participants with molars indicated for full coverage restorations
- Accept to undergo face scanning and articulator mounting procedures
- Have no active periodontal or pulpal diseases, have teeth with clinically acceptable restorations.
Key exclusion criteria (9 listed)
- Participants with active resistant periodontal diseases.
- Participants with poor oral hygiene, high caries risk and uncooperative participants.
- Pregnant women.
- Participants in the growth stage with partially erupted teeth.
- Psychiatric problems or unrealistic expectations.
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 |
|---|---|---|
| Digitized Mounted Articulator ScanConventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. | Procedure or surgery | Digitized Mounted Articulator Scan |
| Average Positioning on Virtual Bonwill TriangleVirtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. | Procedure or surgery | Average Positioning on Virtual Bonwill Triangle |
| Digital Face ScanDigital face scan will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. | Procedure or surgery | Digital Face Scan |
Primary outcome
Clinical Occlusal Adjustment Time
Time frame: Immediately after verification of restoration acceptability but prior to occlusal adjustment. Time will be measured until occlusal contacts of the crown have been harmonized during the delivery clinical visit.
Time taken to harmonize occlusal contacts with participants masticatory function during delivery of the crown.Measured in minutes and seconds.
1 secondary outcome
Volume of Occlusal Adjustment
Time frame: Before and immediately after the occlusal adjustment. Volume before occlusal adjustment - volume after occlusal adjustment of the of the crown = volume difference
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 20 Mar 2026.
- Individual participant dataSharing planned: No. Only outcomes will be shared. Participants' personal information will be stored in a password protected folder.
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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.
Aly AM El-Kady, MSc principal investigator
Fixed Prosthodontics Department, Misr International University
Shereen A Ameen, Prof. Dr. study chair
Fixed Prosthodontics Department, Cairo University
Rasha NM Sami, Prof. Dr. study director
Fixed Prosthodontics Department, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitized Mounted Articulator Scan, Average Positioning on Virtual Bonwill Triangle and Digital Face Scan in people with Dental Occlusion and Crowns, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 9 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 20 Mar 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 Egypt. 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?
Clinical Occlusal Adjustment Time (time frame: Immediately after verification of restoration acceptability but prior to occlusal adjustment. Time will be measured until occlusal contacts of the crown have been harmonized during the delivery clinical visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.