Gingival RecessionNCT06457672
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 Group I and Group II in people with Gingival Recession, 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 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Group I and Group II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2024to 30 Dec 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 years or older.
- 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
- Systemic health conditions that contraindicate or affect healing of periodontal surgery.
- Patients requiring prosthetic crowns or restorations in the esthetic zone.
- Gummy smile with normal tooth proportions.
- Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine).
- Smokers.
- Pregnant and nursing females.
Trial locations and contacts
1 site in 1 country.
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.
Read the detailed description
This study will involve the analysis of digital models in. ply format acquired through intraoral scanning of patients scheduled for esthetic crown lengthening,
- Pre-analytical Phase:
In an interview, a full medical history is obtained. Clinical and radiographic examinations are completed before consent signing for study enrollment.
Full mouth supra and subgingival debridement will be performed for patients using an ultrasonic device with supragingival scaling inserts, followed by Universal or Gracey's curettes for thorough subgingival debridement. Patient preparation will be completed in a single visit. Comprehensive oral hygiene instructions will be provided to the patient, including instructions for brushing teeth twice daily using a soft toothbrush and employing a circular scrub technique.
Additionally, guidance will be given on interdental cleansing, using either waxed dental floss or a toothpick appropriate for the size of the interdental embrasure.
Surgical procedure:
After a period of 4-6 weeks from the initial therapy, patients will be recalled. After ensuring the fulfillment of all inclusion criteria, they will be scheduled for surgery.
Following local anesthesia, the surgical procedure will be initiated with demarcation of CEJ position on the mid-buccal aspect of the teeth. The width of the central incisors will be identified by measuring the teeth width at the level of interproximal contact using UNC periodontal probe. Then the ideal tooth length will be calculated through the central tooth width to length ratio of 75-85%. The canines will be marked at the same level as the central incisors while the lateral incisors will be marked at 1 mm apical to the central incisors. Zenith points will be marked using a tissue pen at 1 mm distally shifted to the midline of centrals, 0.4 mm distally on the laterals, and mostly on the midline of canines (Chu et al., 2009). The interdental papillae levels will be evaluated. If they are situated at a level higher than the half of the adjacent tooth crown, then they will need to be shortened and will be included in the cutting design. If the interdental papillae levels are equal to or less than half the length of the adjacent tooth crown, then the cutting lines will be thinned from the zenith points to the papillae tips (Spear et al., 2006).
An internal bevel incision using #15c blade will be performed following the anatomy of the CEJ. The incision will be made at 45 degrees to the bone at each tooth, preserving the interdental papillae when needed. This will be followed by an intra-sulcular incision in order to remove the strip of the outlined marginal gingiva.
When bone removal is advocated, a full-thickness flap will be elevated to the level of the alveolar bone crest exposing 2-3 mm of bone using a normal mucoperiosteal elevator(Arora et al., 2013). The cementoenamel junction-alveolar bone crest (CEJ-ABC) distance will be measured on the mid-buccal aspect. Then, ostectomy and osteoplasty will be performed using an end-cutting bur and round bur, aiming to attain a 2 mm CEJ-ABC distance for attaining a normal biological width.
Finally, the flap will be repositioned, and simple interrupted sutures of 4/0 vicryl will be used to keep the papillae in place, using a normal needle holder(Palomo \& Kopczyk, 1978;Deas et al., 2004).
- Analytical phase:
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. Implementation of the superimposition: 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.
Superimposition accuracy:
Models will be exported in superimposed orientations to the Geomagic software6 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.
Marginal and Volumetric changes:
For assessing changes at the gingival margin level, all three models will be selected, and a cross section 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.
C.Post-analytical Phase:
The evaluation will be conducted by two periodontists possessing varying levels of experience.
Subsequently, inter-observer agreements will be quantified. To assess intra-observer agreement, one of the two periodontists will perform the evaluation on two occasions, with a two-week interval between each assessment (Vasilakos et al., 2017).
- Conditions
- Gingival Recession
- Being tested
- Group I, Group II
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IDiagnostic test
Complete Crown technique of superimposition
Group IIDiagnostic test
Gold standard technique of superimposition
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | complete crown technique for superimposition of digital models Receives: Diagnostic Test: Group I; Diagnostic Test: Group II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superimposition accuracy
Using Geomagic Software (RMS) in Millimeter(mm)
Measured: 6 months
Secondary outcomes (4)
Soft tissue volumetric Changes
Digital using intraoral scanner and blenderfordental software in Millimeter(mm)
Measured: 6 months
Gingival Margin level change
Digital using intraoral scanner and blenderfordental software in Millimeter(mm)
Measured: 6 months
Intra-Inter Assessor reliability
Intraclass correlation coefficient
Measured: 6 months
Operator's satisfaction
Questionnaire
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 posted13 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457672
- Sponsor's protocol ID
- CU1612
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 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
- NCT06457672
- Acronym / sponsor ID
- CU1612
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jun 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.
Detailed description
This study will involve the analysis of digital models in. ply format acquired through intraoral scanning of patients scheduled for esthetic crown lengthening,
- Pre-analytical Phase:
In an interview, a full medical history is obtained. Clinical and radiographic examinations are completed before consent signing for study enrollment.
Full mouth supra and subgingival debridement will be performed for patients using an ultrasonic device with supragingival scaling inserts, followed by Universal or Gracey's curettes for thorough subgingival debridement. Patient preparation will be completed in a single visit. Comprehensive oral hygiene instructions will be provided to the patient, including instructions for brushing teeth twice daily using a soft toothbrush and employing a circular scrub technique.
Additionally, guidance will be given on interdental cleansing, using either waxed dental floss or a toothpick appropriate for the size of the interdental embrasure.
Surgical procedure:
After a period of 4-6 weeks from the initial therapy, patients will be recalled. After ensuring the fulfillment of all inclusion criteria, they will be scheduled for surgery.
Following local anesthesia, the surgical procedure will be initiated with demarcation of CEJ position on the mid-buccal aspect of the teeth. The width of the central incisors will be identified by measuring the teeth width at the level of interproximal contact using UNC periodontal probe. Then the ideal tooth length will be calculated through the central tooth width to length ratio of 75-85%. The canines will be marked at the same level as the central incisors while the lateral incisors will be marked at 1 mm apical to the central incisors. Zenith points will be marked using a tissue pen at 1 mm distally shifted to the midline of centrals, 0.4 mm distally on the laterals, and mostly on the midline of canines (Chu et al., 2009). The interdental papillae levels will be evaluated. If they are situated at a level higher than the half of the adjacent tooth crown, then they will need to be shortened and will be included in the cutting design. If the interdental papillae levels are equal to or less than half the length of the adjacent tooth crown, then the cutting lines will be thinned from the zenith points to the papillae tips (Spear et al., 2006).
An internal bevel incision using #15c blade will be performed following the anatomy of the CEJ. The incision will be made at 45 degrees to the bone at each tooth, preserving the interdental papillae when needed. This will be followed by an intra-sulcular incision in order to remove the strip of the outlined marginal gingiva.
When bone removal is advocated, a full-thickness flap will be elevated to the level of the alveolar bone crest exposing 2-3 mm of bone using a normal mucoperiosteal elevator(Arora et al., 2013). The cementoenamel junction-alveolar bone crest (CEJ-ABC) distance will be measured on the mid-buccal aspect. Then, ostectomy and osteoplasty will be performed using an end-cutting bur and round bur, aiming to attain a 2 mm CEJ-ABC distance for attaining a normal biological width.
Finally, the flap will be repositioned, and simple interrupted sutures of 4/0 vicryl will be used to keep the papillae in place, using a normal needle holder(Palomo \& Kopczyk, 1978;Deas et al., 2004).
- Analytical phase:
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. Implementation of the superimposition: 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.
Superimposition accuracy:
Models will be exported in superimposed orientations to the Geomagic software6 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.
Marginal and Volumetric changes:
For assessing changes at the gingival margin level, all three models will be selected, and a cross section 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.
C.Post-analytical Phase:
The evaluation will be conducted by two periodontists possessing varying levels of experience.
Subsequently, inter-observer agreements will be quantified. To assess intra-observer agreement, one of the two periodontists will perform the evaluation on two occasions, with a two-week interval between each assessment (Vasilakos et al., 2017).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Diagnostic Test: Group I, Diagnostic Test: Group IIcomplete crown technique for superimposition of digital models |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- 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 (6 listed)
- Systemic health conditions that contraindicate or affect healing of periodontal surgery.
- Patients requiring prosthetic crowns or restorations in the esthetic zone.
- Gummy smile with normal tooth proportions.
- Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine).
- Smokers.
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 |
|---|---|---|
| Group IComplete Crown technique of superimposition | Diagnostic test | group I |
| Group IIGold standard technique of superimposition | Diagnostic test | group I |
Primary outcome
Superimposition accuracy
Time frame: 6 months
Using Geomagic Software (RMS) in Millimeter(mm)
4 secondary outcomes
Soft tissue volumetric Changes
Time frame: 6 months
Gingival Margin level change
Time frame: 6 months
Intra-Inter Assessor reliability
Time frame: 6 months
Operator's satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I and Group II in people with Gingival Recession, 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 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 13 Jun 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 Ahmed Hassan (01060683334, 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 13 Jun 2024.