Dental OcclusionNCT06272474
Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments
A study testing CAD-CAM zirconia crowns using buccal interocclusal record. and CAD-CAM zirconia crowns using lateral interocclusal records. in people with Dental Occlusion, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Dental Occlusion
- What is being tested?
- CAD-CAM zirconia crowns using buccal interocclusal record. and CAD-CAM zirconia crowns using lateral interocclusal records.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2022to 9 Dec 2023
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient presented with successful endodontically treated maxillary 1st premolar.
- Patients having class I occlusion.
- Good oral hygiene with no signs of periapical pathology or periodontal disease(24).
- Patient having natural teeth as opposed to dentition.
Who cannot join
- Pregnancy, which prevents the use of diagnostic x-rays.
- Parafunctional habits.
- Mobility in the abutment teeth more than grade 1.
- Patient presenting allergy to materials being used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments of Designed and Milled Cad-cam Zirconia Crowns; a Diagnostic Accuracy Trial
Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.
The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.
Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained.
- Conditions
- Dental Occlusion
- Being tested
- CAD-CAM zirconia crowns using buccal interocclusal record., CAD-CAM zirconia crowns using lateral interocclusal records.
- 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.
CAD-CAM zirconia crowns using buccal interocclusal record.Other
Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record.
First, scanning the buccal interocclusal record for each patient with the two arches in maximum intercuspation position (MIP) will be performed. The IOS will immediately reproduce the occlusal state of the digital casts; this method is called the buccal bite registration method (BBR).
CAD-CAM zirconia crowns using lateral interocclusal records.Other
Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using lateral interocclusal record.
A second scan will be performed for each patient to record lateral mandibular excursion. Then, three STL files will be exported; maxillary arch, mandibular arch at MIP and lateral mandibular excursion
| Study group | Role | What they receive |
|---|---|---|
| Buccal interocclusal records | Active comparator | Not described Receives: Other: CAD-CAM zirconia crowns using buccal interocclusal record. |
| Lateral interocclusal records | Experimental | Not described Receives: Other: CAD-CAM zirconia crowns using lateral interocclusal records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static occlusal interference
it is measured at patient's maximum intercuspation using occlusense device
Measured: Through study completion, average 12 months
Dynamic occlusal interference
it is measured at patient's lateral mandibular movement using occlusense device
Measured: Through study completion, average 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start11 Sep 2022
- Primary completion9 Dec 2023
- Study completion9 Dec 2023
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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single group is receiving the two interventional arms
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272474
- Sponsor's protocol ID
- 0266-07/2021 - 18/07/2021
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments of Designed and Milled Cad-cam Zirconia Crowns; a Diagnostic Accuracy Trial
- ClinicalTrials.gov ID
- NCT06272474
- Acronym / sponsor ID
- 0266-07/2021 - 18/07/2021
- Conditions
- Dental Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 22 Feb 2024 (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.
Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.
The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.
Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single group is receiving the two interventional arms
| Arm | Type | Receives |
|---|---|---|
| Buccal interocclusal records | Active comparator | Other: CAD-CAM zirconia crowns using buccal interocclusal record. |
| Lateral interocclusal records | Experimental | Other: CAD-CAM zirconia crowns using lateral interocclusal records. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient presented with successful endodontically treated maxillary 1st premolar.
- Patients having class I occlusion.
- Good oral hygiene with no signs of periapical pathology or periodontal disease(24).
- Patient having natural teeth as opposed to dentition.
Key exclusion criteria (4 listed)
- Pregnancy, which prevents the use of diagnostic x-rays.
- Parafunctional habits.
- Mobility in the abutment teeth more than grade 1.
- Patient presenting allergy to materials being used.
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 |
|---|---|---|
| CAD-CAM zirconia crowns using buccal interocclusal record.Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record. First, scanning the buccal interocclusal record for each patient with the two arches in maximum intercuspation position (MIP) will be performed. The IOS will immediately reproduce the occlusal state of the digital casts; this method is called the buccal bite registration method (BBR). | Other | Buccal interocclusal records |
| CAD-CAM zirconia crowns using lateral interocclusal records.Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using lateral interocclusal record. A second scan will be performed for each patient to record lateral mandibular excursion. Then, three STL files will be exported; maxillary arch, mandibular arch at MIP and lateral mandibular excursion | Other | Lateral interocclusal records |
Primary outcome
Static occlusal interference
Time frame: Through study completion, average 12 months
it is measured at patient's maximum intercuspation using occlusense device
Dynamic occlusal interference
Time frame: Through study completion, average 12 months
it is measured at patient's lateral mandibular movement using occlusense device
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 22 Feb 2024.
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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 CAD-CAM zirconia crowns using buccal interocclusal record. and CAD-CAM zirconia crowns using lateral interocclusal records. in people with Dental Occlusion, run by Hams Hamed Abdelrahman 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 4 inclusion and 4 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 22 Feb 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?
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?
Static occlusal interference (time frame: Through study completion, average 12 months). The study lists 2 primary outcomes in all. 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 22 Feb 2024.