Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457672
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief 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
Sponsor:
British University In Egypt
Organization:
British University In Egypt
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
A 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 Graceys 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 04 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 elevatorArora 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 40 vicryl will be used to keep the papillae in place using a normal needle holderPalomo Kopczyk 1978Deas et al 2004
B 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 moving001 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 softwares 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
CPost-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
A 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 Graceys 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 04 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 elevatorArora 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 40 vicryl will be used to keep the papillae in place using a normal needle holderPalomo Kopczyk 1978Deas et al 2004
B 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 moving001 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 softwares 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
CPost-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None