Volume AssessmentNCT06673576
Assessment of The Accuracy of Complete Crown 3D Superimposition Technique Relative to The Gold Standard Technique for Digital Quantification of Volumetric Soft Tissue Changes in The Esthetic Zone
A study testing Complete crown technique for superimposition and Gold standard technique for superimposition in people with Volume Assessment and Gummy Smile, run by British University In Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to assess the precision of the complete crown technique employed for the superimposition of 3D models, specifically in the quantitative volumetric evaluation of gingival tissues. This technique was initially introduced in an in-vitro study by Dritsas et al. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volume Assessment, Gummy Smile
- What is being tested?
- Complete crown technique for superimposition and Gold standard technique for superimposition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring esthetic crown lengthening.
- Full-mouth plaque and bleeding score not exceeding 20%.
- Presence of at least 2.5 mm keratinized tissue width (Pontoriero \& Carnevale, 2001).
- Patients showing motivation to comply with post-operative care instructions and follow-up appointments.
Who cannot join
- 1. Systemic health conditions that contraindicate or affect healing of periodontal surgery.
- 2. Patients requiring prosthetic crowns or restorations in the esthetic zone. 3. Gummy smile with normal tooth proportions. 4. Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine).
- 5. Smokers. 6. Pregnant and nursing females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11230
Samah Bahaa, Lecturer, +20 100 680 6808, samah.bahaa@dentistry.cu.edu.eg
About this study
The aim of this study is to assess the precision of the complete crown technique employed for the superimposition of 3D models, specifically in the quantitative volumetric evaluation of gingival tissues. This technique was initially introduced in an in-vitro study by Dritsas et al. (2023) as a means to achieve an accurate, reproducible, and simple method for quantification of gingival recession.
This study will involve the analysis of digital models in. ply format acquired through intraoral scanning of patients scheduled for esthetic crown lengthening, with predefined inclusion and exclusion
Read the detailed description
A digital model T0 (presurgical scan) will be acquired, and the mesh structure will undergo meticulous examination to identify any instances of voids or distorted mesh networks.
Patients will be followed-up for 6 months then undergo the second intraoral scan T6 (6 months follow-up). The resultant mesh structure will be carefully inspected for any defects.
The digital models in. ply format corresponding to T0 (presurgical scan) and T6 (6 months follow-up) will be imported into the BlenderForDental5 software. Notably, the T6 model will be imported twice. Each model will go through a trimming process utilizing the arch cut tool. Subsequently, a base will be created for each model employing the model base tool. A thorough inspection is performed to identify any potential voids in the model base. In cases where voids are detected, the "fill holes" tool will be employed to rectify and fill any voids present within the model base.
Utilizing the superimposition tool, an initial manual alignment of the digital models will be performed, followed by the superimposition procedure. The T0 model will be designated as the reference model, while the first T6 model will be chosen as the moving model. The second T6 model will be designated as the moving.001 model. For the complete crown technique, the crown of the tooth corresponding to the gingival margin under evaluation will be selected using the paint method and circular selection tool. The same selection process will be applied to the moving model. In the case of the gold standard technique, adjacent intact teeth and a portion of the palatal gingiva will be selected. Superimpositions will be executed utilizing the software's iterative closest point algorithm (ICP). A heat map will be generated to verify the accuracy of the superimposition process.
Models will be exported in superimposed orientations to the Geomagic software for the measurement of superimposition accuracy, specifically the root mean square of the tooth corresponding to the gingival margin where volumetric changes are of interest, using the 3D compare tool in Geomagic software.
- Conditions
- Volume Assessment, Gummy Smile
- Being tested
- Complete crown technique for superimposition, Gold standard technique for superimposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete crown technique for superimpositionDiagnostic test
the complete crown technique, the crown of the tooth corresponding to the gingival margin under evaluation will be selected using the paint method and circular selection tool. The same selection process will be applied to the moving model.
Gold standard technique for superimpositionDiagnostic test
the gold standard technique, adjacent intact teeth and a portion of the palatal gingiva will be selected. Superimpositions will be executed utilizing the software's iterative closest point algorithm (ICP).
| Study group | Role | What they receive |
|---|---|---|
| Patients assigned for esthetic crown leghthening | Experimental | Not described Receives: Diagnostic Test: Complete crown technique for superimposition; Diagnostic Test: Gold standard technique for superimposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superimposition accuracy
Models will be exported in superimposed orientations to the Geomagic software for the measurement of superimposition accuracy, specifically the root mean square of the tooth corresponding to the gingival margin where volumetric changes are of interest, using the 3D compare tool in Geomagic software.
Measured: 6 months
Secondary outcomes (1)
Marginal and Volumetric changes
For assessing changes at the gingival margin level, all three models will be selected, and a crosssection will be generated at the center of the targeted tooth, followed by linear measurements.
To evaluate volumetric changes, a Boolean modifier will be applied between the T0 model and the T6 model. Excess mesh vertices will then be removed using the clean model tool. Subsequently, the excised gingival margin will become readily apparent and quantifiable, allowing for the measurement of its volume through the utilization of the 3D print module within the BlenderForDental software.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Mar 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume AssessmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed Mohamed Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673576
- Sponsor's protocol ID
- 131024
- Status last verified
- Nov 2024
- First submitted
- 13 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of The Accuracy of Complete Crown 3D Superimposition Technique Relative to The Gold Standard Technique for Digital Quantification of Volumetric Soft Tissue Changes in The Esthetic Zone
- ClinicalTrials.gov ID
- NCT06673576
- Acronym / sponsor ID
- 131024
- Conditions
- Volume Assessment, Gummy Smile
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 5 Nov 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.
The aim of this study is to assess the precision of the complete crown technique employed for the superimposition of 3D models, specifically in the quantitative volumetric evaluation of gingival tissues. This technique was initially introduced in an in-vitro study by Dritsas et al. (2023) as a means to achieve an accurate, reproducible, and simple method for quantification of gingival recession.
This study will involve the analysis of digital models in. ply format acquired through intraoral scanning of patients scheduled for esthetic crown lengthening, with predefined inclusion and exclusion
Detailed description
A digital model T0 (presurgical scan) will be acquired, and the mesh structure will undergo meticulous examination to identify any instances of voids or distorted mesh networks.
Patients will be followed-up for 6 months then undergo the second intraoral scan T6 (6 months follow-up). The resultant mesh structure will be carefully inspected for any defects.
The digital models in. ply format corresponding to T0 (presurgical scan) and T6 (6 months follow-up) will be imported into the BlenderForDental5 software. Notably, the T6 model will be imported twice. Each model will go through a trimming process utilizing the arch cut tool. Subsequently, a base will be created for each model employing the model base tool. A thorough inspection is performed to identify any potential voids in the model base. In cases where voids are detected, the "fill holes" tool will be employed to rectify and fill any voids present within the model base.
Utilizing the superimposition tool, an initial manual alignment of the digital models will be performed, followed by the superimposition procedure. The T0 model will be designated as the reference model, while the first T6 model will be chosen as the moving model. The second T6 model will be designated as the moving.001 model. For the complete crown technique, the crown of the tooth corresponding to the gingival margin under evaluation will be selected using the paint method and circular selection tool. The same selection process will be applied to the moving model. In the case of the gold standard technique, adjacent intact teeth and a portion of the palatal gingiva will be selected. Superimpositions will be executed utilizing the software's iterative closest point algorithm (ICP). A heat map will be generated to verify the accuracy of the superimposition process.
Models will be exported in superimposed orientations to the Geomagic software for the measurement of superimposition accuracy, specifically the root mean square of the tooth corresponding to the gingival margin where volumetric changes are of interest, using the 3D compare tool in Geomagic software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients assigned for esthetic crown leghthening | Experimental | Diagnostic Test: Complete crown technique for superimposition, Diagnostic Test: Gold standard technique for superimposition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients requiring esthetic crown lengthening.
- Full-mouth plaque and bleeding score not exceeding 20%.
- Presence of at least 2.5 mm keratinized tissue width (Pontoriero \& Carnevale, 2001).
- Patients showing motivation to comply with post-operative care instructions and follow-up appointments.
Key exclusion criteria (3 listed)
- 1. Systemic health conditions that contraindicate or affect healing of periodontal surgery.
- 2. Patients requiring prosthetic crowns or restorations in the esthetic zone. 3. Gummy smile with normal tooth proportions. 4. Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine).
- 5. Smokers. 6. Pregnant and nursing females.
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 |
|---|---|---|
| Complete crown technique for superimpositionthe complete crown technique, the crown of the tooth corresponding to the gingival margin under evaluation will be selected using the paint method and circular selection tool. The same selection process will be applied to the moving model. | Diagnostic test | Patients assigned for esthetic crown leghthening |
| Gold standard technique for superimpositionthe gold standard technique, adjacent intact teeth and a portion of the palatal gingiva will be selected. Superimpositions will be executed utilizing the software's iterative closest point algorithm (ICP). | Diagnostic test | Patients assigned for esthetic crown leghthening |
Primary outcome
Superimposition accuracy
Time frame: 6 months
Models will be exported in superimposed orientations to the Geomagic software for the measurement of superimposition accuracy, specifically the root mean square of the tooth corresponding to the gingival margin where volumetric changes are of interest, using the 3D compare tool in Geomagic software.
1 secondary outcome
Marginal and Volumetric changes
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete crown technique for superimposition and Gold standard technique for superimposition in people with Volume Assessment and Gummy Smile, run by British University In Egypt 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 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: looking for participants now, as of the sponsor's last update on 5 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed Hassan, Master Degree of Periodontolog (+201060683334, ahmed.hasan@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superimposition accuracy (time frame: 6 months). 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 5 Nov 2024.