Marginal Adaptation of Fixed Dental ProsthesisNCT04653519
Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering
A study testing Virtually guided minimally invasive preparation in people with Marginal Adaptation of Fixed Dental Prosthesis, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the study is to assess and reproduce standardized virtually guided minimally invasive tooth preparations using digitally designed occlusal template, compared to its reference virtual preparation using a computer aided 3-dimensional (3-D) analysis, and to investigate the effect of these preparations on… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Marginal Adaptation of Fixed Dental Prosthesis
- What is being tested?
- Virtually guided minimally invasive preparation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to Jan 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a missing lower first mandibular molar.
- Good oral hygiene with no signs of periapical pathology or periodontal disease (periodontal screening index 0-1) and with compliance to perform strict oral hygiene measures.
- Well-aligned abutment teeth with similar mesio-distal (M-D) and bucco-lingual (B- L) dimensions; (2nd premolar: M-D 7.8 mm ±1, B-L 8.7 mm ±1), (2nd molar: M-D 10.73±1, B-L 10.5 mm ±1).
- Abutment teeth with an adequate occluso-gingival height where (2nd premolar: 8.4 mm ±1, 2nd molar 7mm ±1), and adequate edentulous span length (9.5 mm±1); for an appropriate connector area of at least 9 mm.
- Absence of parafunctional habits (clinching, bruxism).
Who cannot join
- Bad oral hygiene.
- Advanced periodontitis, gingivitis, or recession.
- Abutments with subgingival restorations, root caries.
- Parafunctional habits.
- Undergoing orthodontic treatment.
- Obvious dentition malalignment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria, 21527
Yara H Attia, M.Sc, 01002539089 ext. +2, yha11@fayoum.edu.eg
About this study
Official title: Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering (Controlled Clinical Trial)
The aim of the study is to assess and reproduce standardized virtually guided minimally invasive tooth preparations using digitally designed occlusal template, compared to its reference virtual preparation using a computer aided 3-dimensional (3-D) analysis, and to investigate the effect of these preparations on absolute marginal discrepancy of 3 unit monolithic translucent zirconia FPD using a computer aided 3-D analysis.
Read the detailed description
Ten patients with missing mandibular first molar will receive a three-unit full contour monolithic zirconia FPD. Each patient case will receive two modes of preparation as in the previous in-vitro study: virtually guided tooth preparation using occlusal resin template to assist the intraoral preparation and the reference virtual tooth preparation. Each participant's preparation will be evaluated using diagnostic dental software and will be compared to a reference digital virtual preparation using 3-D mesh processing reverse engineering metrology software.
- Being tested
- Virtually guided minimally invasive preparation
- Keywords
- Minimally invasive tooth preparations, Reverse engineering, Virtually guided tooth preparation, Digital assessment of tooth preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually guided minimally invasive preparationDevice
Intraoral virtually guided minimally invasive design with an occlusal reduction of 1.5mm, axial reduction will be performed with 6 degrees axial taper and a circumferential chamfer margin of 0.5mm in width and 0.5mm coronal to the gingival margin. A milled guiding occlusal resin template of the teeth will be checked for fitting then fixed using spot etching and will be used to guide the amount of axial reductions and taper degree.
| Study group | Role | What they receive |
|---|---|---|
| Virtually guided minimally invasive preparation | Experimental | Not described Receives: Device: Virtually guided minimally invasive preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the virtually guided tooth preparation accuracy
Each scan data of virtually guided preparations will be uploaded to a 3D mesh processing reverse engineering software, then superimposed against the reference virtual preparation using the software's best fit matching algorithm tool. Superimposed 3D data files will be sectioned into 5 different 2D planes: buccolingual, mesiodistal, transverse occlusal, transverse middle, and transverse gingival. Differences will be assessed both qualitatively and quantitively to measure deviations. Quantitative assessment will be expressed with a sign: (+) indicating external deviation or (-) indicating internal deviation. The deviation (+ or -) will be numerically described with mean and standard deviation. Qualitative assessment will be through a color-coded mapping of superimposed images where discrepancies between each test specimen and reference file will be expressed with yellow range of color lines indicating external deviations and cyan range of color lines indicating internal deviations
Measured: 1 month
3-D Evaluation of absolute marginal discrepancy using reverse engineering
Four scans will be performed using a calibrated laboratory scanner: each 3D printed master cast with 2 preparations designs, external \& intaglio surfaces of monolithic zirconia 3-unit FPDs, monolithic zirconia 3-unit FPDs after it has been seated on each preparation design. The 3D point clouds of all 4 scans will be obtained in STL format. The 3D data of the FPD retainers will be registered to the data obtained from the external surface of the crown using registration module in reverse engineering software. The 3D data of the virtual seating of the intaglio \& external surfaces on the preparations will be obtained \& margins of the FPD retainers \& preparations will be extracted. The software's construct cross-sectional cloud circular command to divide the preparation evenly into curves. Every curve will intersect with the outer edge of the ceramic retainer \& margin design of the preparation at 2 points. Distance between these 2 points will be recorded (absolute marginal discrepancy)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start20 Sep 2020
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Adaptation of Fixed Dental ProsthesisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yara attia, Fayoum University
- Investigators
- Yara H Attia, M.Sc, Principal investigator, Faculty of Dentistry, Fayoum University, EgyptSamir I Bakry, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptSanaa H Abd El Kader, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653519
- Sponsor's protocol ID
- 0155-09/2020
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 4 Dec 2020
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering (Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04653519
- Acronym / sponsor ID
- 0155-09/2020
- Keywords
- Minimally invasive tooth preparations, Reverse engineering, Virtually guided tooth preparation, Digital assessment of tooth preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Dec 2020 (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.
The aim of the study is to assess and reproduce standardized virtually guided minimally invasive tooth preparations using digitally designed occlusal template, compared to its reference virtual preparation using a computer aided 3-dimensional (3-D) analysis, and to investigate the effect of these preparations on absolute marginal discrepancy of 3 unit monolithic translucent zirconia FPD using a computer aided 3-D analysis.
Detailed description
Ten patients with missing mandibular first molar will receive a three-unit full contour monolithic zirconia FPD. Each patient case will receive two modes of preparation as in the previous in-vitro study: virtually guided tooth preparation using occlusal resin template to assist the intraoral preparation and the reference virtual tooth preparation. Each participant's preparation will be evaluated using diagnostic dental software and will be compared to a reference digital virtual preparation using 3-D mesh processing reverse engineering metrology software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtually guided minimally invasive preparation | Experimental | Device: Virtually guided minimally invasive preparation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with a missing lower first mandibular molar.
- Good oral hygiene with no signs of periapical pathology or periodontal disease (periodontal screening index 0-1) and with compliance to perform strict oral hygiene measures.
- Well-aligned abutment teeth with similar mesio-distal (M-D) and bucco-lingual (B- L) dimensions; (2nd premolar: M-D 7.8 mm ±1, B-L 8.7 mm ±1), (2nd molar: M-D 10.73±1, B-L 10.5 mm ±1).
- Abutment teeth with an adequate occluso-gingival height where (2nd premolar: 8.4 mm ±1, 2nd molar 7mm ±1), and adequate edentulous span length (9.5 mm±1); for an appropriate connector area of at least 9 mm.
- Absence of parafunctional habits (clinching, bruxism).
Key exclusion criteria (6 listed)
- Bad oral hygiene.
- Advanced periodontitis, gingivitis, or recession.
- Abutments with subgingival restorations, root caries.
- Parafunctional habits.
- Undergoing orthodontic treatment.
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 |
|---|---|---|
| Virtually guided minimally invasive preparationIntraoral virtually guided minimally invasive design with an occlusal reduction of 1.5mm, axial reduction will be performed with 6 degrees axial taper and a circumferential chamfer margin of 0.5mm in width and 0.5mm coronal to the gingival margin. A milled guiding occlusal resin template of the teeth will be checked for fitting then fixed using spot etching and will be used to guide the amount of axial reductions and taper degree. | Device | Virtually guided minimally invasive preparation |
Primary outcome
Evaluation of the virtually guided tooth preparation accuracy
Time frame: 1 month
Each scan data of virtually guided preparations will be uploaded to a 3D mesh processing reverse engineering software, then superimposed against the reference virtual preparation using the software's best fit matching algorithm tool. Superimposed 3D data files will be sectioned into 5 different 2D planes: buccolingual, mesiodistal, transverse occlusal, transverse middle, and transverse gingival. Differences will be assessed both qualitatively and quantitively to measure deviations. Quantitative assessment will be expressed with a sign: (+) indicating external deviation or (-) indicating internal deviation. The deviation (+ or -) will be numerically described with mean and standard deviation. Qualitative assessment will be through a color-coded mapping of superimposed images where discrepancies between each test specimen and reference file will be expressed with yellow range of color lines indicating external deviations and cyan range of color lines indicating internal deviations
3-D Evaluation of absolute marginal discrepancy using reverse engineering
Time frame: 1 month
Four scans will be performed using a calibrated laboratory scanner: each 3D printed master cast with 2 preparations designs, external \& intaglio surfaces of monolithic zirconia 3-unit FPDs, monolithic zirconia 3-unit FPDs after it has been seated on each preparation design. The 3D point clouds of all 4 scans will be obtained in STL format. The 3D data of the FPD retainers will be registered to the data obtained from the external surface of the crown using registration module in reverse engineering software. The 3D data of the virtual seating of the intaglio \& external surfaces on the preparations will be obtained \& margins of the FPD retainers \& preparations will be extracted. The software's construct cross-sectional cloud circular command to divide the preparation evenly into curves. Every curve will intersect with the outer edge of the ceramic retainer \& margin design of the preparation at 2 points. Distance between these 2 points will be recorded (absolute marginal discrepancy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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.
Yara H Attia, M.Sc principal investigator
Faculty of Dentistry, Fayoum University, Egypt
Samir I Bakry, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Sanaa H Abd El Kader, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually guided minimally invasive preparation in people with Marginal Adaptation of Fixed Dental Prosthesis, run by Alexandria 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 5 inclusion and 6 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 4 Dec 2020. 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 Yara H Attia, M.Sc (01002539089 ext. +2, yha11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the virtually guided tooth preparation accuracy (time frame: 1 month). 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 4 Dec 2020.