Dentoalveolar DeformitiesNCT06168279
Virtual Digital Articulation Versus Hand-articulation Accuracy for Occlusal Registration in Orthognathic Surgery
A study testing hand occlusal articulation and digital occlusal articulation in people with Dentoalveolar Deformities, run by Cairo University at 1 site in Egypt.
Trial summary
Conventionally, orthognathic occlusal planning is performed by physically articulating the study models until a well interdigitated occlusion is achieved. this is undertaken in conjunction with the analysis of the face and jaw bones for surgical planning. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentoalveolar Deformities
- What is being tested?
- hand occlusal articulation and digital occlusal articulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 30 Sep 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age arrange from 18-40 yr
- Patient requiring orthognathic surgery to correct dentofacial occlusion deformity
- Patient should be free from any significant medical condition that could affect healing or outcomes
Who cannot join
- • One or more missing central incisors, canines, and/or first molars
- Patient with facial cleft
- Patient with significant medical condition
Trial locations and contacts
1 site in 1 country.
Mohamed Farid, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Abdullah
Cairo
Abdullah Gamal Abdullah, 00201003314856, Awqblue13@yahoo.com
About this study
Official title: Assessment of Virtual Digital Articulation Versus Hand-articulation Accuracy for Occlusal Registration in Orthognathic Surgery (Randomized Clinical Trial)
Conventionally, orthognathic occlusal planning is performed by physically articulating the study models until a well interdigitated occlusion is achieved. this is undertaken in conjunction with the analysis of the face and jaw bones for surgical planning.
Computer-assisted planning now allows digital planning of orthognathic surgery, including assessment of the quality of the final occlusion and printing of the guiding occlusal wafers. This can be achieved through the replacement of the defective images of the dentition produced by the cone beam computed tomography (CBCT) scan with accurate digital images of the study models, captured using CBCT or laser scanning
Read the detailed description
The determination of an ideal dental occlusion is a vital step in planning orthognathic surgery. Conventionally, a dental occlusion is determined using model surgery based on two dimensional cephalometric planning for the movement of maxillary and mandibular segments. Later, acrylic surgical splints were fabricated in the articulator and used in operating rooms to reposition jaw bones. This conventional method is well established, widely used, and inexpensive. However, its main disadvantages are that patients experience discomfort during the impression procedure, and making dental models and performing model surgery are time consuming. In addition, there is a need for storing dental casts, and errors may occur during this procedure. Computer-aided simulation surgery and three-dimensional planning have become popular. Nadjmi et al. proposed an experimental method for virtual occlusions and demonstrated that the mean distance between their conventional and virtual manual occlusion was small. Adolphs et al. scanned a dental cast and aligned the tooth image for a virtual occlusion by using a software program and reported no difference between the virtual and traditional splint when fitted to a patient's dentition. Wu et al. proposed an experimental haptic simulation framework to determine the virtual occlusion in digital models and showed that the translation and angular deviation of virtual results were smaller compared with the benchmark. However, because the conventional dental impression and model are still required in the computer-aided system and the occlusion setup is determined by the dental model, it cannot be described as fully digital three dimensional planning.
Intraoral digital scanning is an innovative dental technology that has advanced the field of prosthodontics and orthodontics. This technique has been introduced as an alternative to the conventional method for scanning patients' dentition and has become a convenient method for digital impression and model fabrication.The scans can be imported to a software program for planning orthodontic treatment. However, the use of intraoral scanning for the digital setup of the final dental occlusion in three-dimensional orthognathic surgery planning has not yet been reported.
- Conditions
- Dentoalveolar Deformities
- Being tested
- hand occlusal articulation, digital occlusal articulation
- Keywords
- digital occlusal articulation, virtual occlusal registration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand occlusal articulationProcedure or surgery
The upper and lower cast will be scanning separately then will be articulated manually in the final occlusion then scanned after that the stl file will insert to the software to complete virtual planning of orthognathic surgery to made splints that will be using in the operation
digital occlusal articulationProcedure or surgery
Both upper and lower casts will be scanning separately, then the 3D casts will be articulating by using 3d virtual program to obtained the final occlusion after that the stl file will insert to the software to complete virtual planning of orthognathic surgery to made splints that will be using in the operation
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | hand occlusal articulation Receives: Procedure: hand occlusal articulation |
| study group | Active comparator | digital occlusal articulation Receives: Procedure: digital occlusal articulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of occlusal registration
The study will be comparing accuracy in occlusal registration ( between peroperative occlusal registration and postoperative occlusal registration ) between the two groups conventional (hand occlusal articulation) and study group (digital virtual occlusal articulation)
accuracy will be assessed through measuring difference between preoperative and postoperative in software using reference points. measurement will be in millimeters
Measured: immediate after one month of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentoalveolar DeformitiesStudies 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
- Parallel groups
- Model description
- comparison between conventional occlusal articulation and virtual occlusal articulation for accurate of occlusal registration
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdullah gamal abdullah alawlaqi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168279
- Sponsor's protocol ID
- omfs 337
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Virtual Digital Articulation Versus Hand-articulation Accuracy for Occlusal Registration in Orthognathic Surgery (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06168279
- Acronym / sponsor ID
- omfs 337
- Conditions
- Dentoalveolar Deformities
- Keywords
- digital occlusal articulation, virtual occlusal registration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Dec 2023 (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.
Conventionally, orthognathic occlusal planning is performed by physically articulating the study models until a well interdigitated occlusion is achieved. this is undertaken in conjunction with the analysis of the face and jaw bones for surgical planning.
Computer-assisted planning now allows digital planning of orthognathic surgery, including assessment of the quality of the final occlusion and printing of the guiding occlusal wafers. This can be achieved through the replacement of the defective images of the dentition produced by the cone beam computed tomography (CBCT) scan with accurate digital images of the study models, captured using CBCT or laser scanning
Detailed description
The determination of an ideal dental occlusion is a vital step in planning orthognathic surgery. Conventionally, a dental occlusion is determined using model surgery based on two dimensional cephalometric planning for the movement of maxillary and mandibular segments. Later, acrylic surgical splints were fabricated in the articulator and used in operating rooms to reposition jaw bones. This conventional method is well established, widely used, and inexpensive. However, its main disadvantages are that patients experience discomfort during the impression procedure, and making dental models and performing model surgery are time consuming. In addition, there is a need for storing dental casts, and errors may occur during this procedure. Computer-aided simulation surgery and three-dimensional planning have become popular. Nadjmi et al. proposed an experimental method for virtual occlusions and demonstrated that the mean distance between their conventional and virtual manual occlusion was small. Adolphs et al. scanned a dental cast and aligned the tooth image for a virtual occlusion by using a software program and reported no difference between the virtual and traditional splint when fitted to a patient's dentition. Wu et al. proposed an experimental haptic simulation framework to determine the virtual occlusion in digital models and showed that the translation and angular deviation of virtual results were smaller compared with the benchmark. However, because the conventional dental impression and model are still required in the computer-aided system and the occlusion setup is determined by the dental model, it cannot be described as fully digital three dimensional planning.
Intraoral digital scanning is an innovative dental technology that has advanced the field of prosthodontics and orthodontics. This technique has been introduced as an alternative to the conventional method for scanning patients' dentition and has become a convenient method for digital impression and model fabrication.The scans can be imported to a software program for planning orthodontic treatment. However, the use of intraoral scanning for the digital setup of the final dental occlusion in three-dimensional orthognathic surgery planning has not yet been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison between conventional occlusal articulation and virtual occlusal articulation for accurate of occlusal registration
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Procedure: hand occlusal articulationhand occlusal articulation |
| study group | Active comparator | Procedure: digital occlusal articulationdigital occlusal articulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age arrange from 18-40 yr
- Patient requiring orthognathic surgery to correct dentofacial occlusion deformity
- Patient should be free from any significant medical condition that could affect healing or outcomes
Key exclusion criteria (3 listed)
- • One or more missing central incisors, canines, and/or first molars
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 |
|---|---|---|
| hand occlusal articulationThe upper and lower cast will be scanning separately then will be articulated manually in the final occlusion then scanned after that the stl file will insert to the software to complete virtual planning of orthognathic surgery to made splints that will be using in the operation | Procedure or surgery | conventional group |
| digital occlusal articulationBoth upper and lower casts will be scanning separately, then the 3D casts will be articulating by using 3d virtual program to obtained the final occlusion after that the stl file will insert to the software to complete virtual planning of orthognathic surgery to made splints that will be using in the operation | Procedure or surgery | study group |
Primary outcome
accuracy of occlusal registration
Time frame: immediate after one month of procedure
The study will be comparing accuracy in occlusal registration ( between peroperative occlusal registration and postoperative occlusal registration ) between the two groups conventional (hand occlusal articulation) and study group (digital virtual occlusal articulation) accuracy will be assessed through measuring difference between preoperative and postoperative in software using reference points. measurement will be in millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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.
Mohamed Farid, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand occlusal articulation and digital occlusal articulation in people with Dentoalveolar Deformities, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Gamal, Phd (00201003314856, Awqblue13@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of occlusal registration (time frame: immediate after one month of procedure). 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 14 May 2024.