Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393582
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-23
Brief Title:
Accuracy Evaluation of Implant Impressions A Prospective Study
Sponsor:
University of Sharjah
Organization:
University of Sharjah
Study Overview
Official Title:
Accuracy Evaluation of Full-arch Implant Impressions Using Different Workflows A Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 aims of this clinical study are 1 to compare the accuracy of conventional versus digital impression techniques for implant impressions 2 to assess the passive fit of the prosthesis constructed from the most accurate impression
Thirty edentulous patients who received 4 - 6 implant and indicated for implant-supported fixed prosthesis will be invited Full-arch conventional and digital impressions will be made for each patient Accuracy evaluation will be made and the prosthesis will be constructed from the most accurate impression Passive fit of the zirconia implant-supported prostheses will be verified at the try-in stage clinically and radiographically
Thirty edentulous patients who received 4 - 6 implant and indicated for implant-supported fixed prosthesis will be invited Full-arch conventional and digital impressions will be made for each patient Accuracy evaluation will be made and the prosthesis will be constructed from the most accurate impression Passive fit of the zirconia implant-supported prostheses will be verified at the try-in stage clinically and radiographically
Detailed Description:
The aims of this clinical study are 1 to compare the accuracy of conventional versus digital impression techniques for implant impressions 2 to assess the passive fit of the prosthesis constructed from the most accurate impression
Study design The ethical approval will be obtained from the research ethics board Thirty edentulous patients who received 4 - 6 implant and indicated for implant-supported fixed prosthesis will be invited All participants will require to read and sign the informed consent form before initiation of the treatment The impression procedures will be performed by one experienced prosthodontist The prostheses will be evaluated by an independent prosthodontist
Sample size calculation The sample size is calculated based on the tests for paired means With α 005 β 02 mean of distance deviation IOS 17 μm and standard deviation 34 μm a sample size of 25 is necessary which would have the power of 90 to detect the difference Therefore a total of 25 patients will be invited to participate in this clinical study This sample size is more than previous studies evaluating IOS and SPG workflows 15 - 17 patients However it has been reported that the dropout rate in clinical studies is 20 For this reason a total of 30 patients will be invited to compensate for the anticipated loss of patients
Treatment procedure Conventional impression Abutment-level impression copings will hand tightened onto the abutments and splinted with autopolymerizing acrylic resin Pattern Resin GC and allowed to polymerize A custom open-tray splinted impressions will be made with a polyether material Impregum Penta Soft 3M ESPE After 5 minutes the impression copings will be unscrewed from the implants and the impression will be removed Type IV dental stone dentostone 220 dentona AG will be poured into the impression to generate a definitive cast The models will be digitalized with a high-resolution laboratory scanner E4 3Shape AS with an accuracy of 4 mm to obtain the 3D data of the models in standard tessellation language STL format
Digital impressions After tightening the scan bodies CARES RC Mono Scan body Straumann Basel Switzerland the intraoral scanner will be used according to the manufacturers recommendations Three scanners will be used since they have different ways of obtaining 3D images and working principles The technology of Trios scanner TRIOS 4 3Shape AS depends on confocal microscopy ultrafast optical scanning and auto-correction Cerec Primescan Dentsply Sirona depends on optical triangulation and confocal microscopy Medit i700 Medit Seoul Korea depends on 3D in-motion video technology 3D full-color streaming capture and advance algorithm to stitch images The scanning path will begin with the occlusal surfaces then turned to the palatal or lingual surfaces and lastly to the buccal surfaces of the scan bodies Then removing the scan body with a trim tool from the occlusal view and exporting the STL file
Accuracy measurement All STL files generated from the intraoral scan STL digital and the STL files generated from cast digitization STL conventional will be imported into 3D inspection software Geomagic 3D Systems Inc Rock Hill SC for merging and evaluation of 3D deviations Following software best-fit alignment the 3D comparison will be used to evaluate the 3D deviations between the digital files STL files from IOS and digitized conventional working casts limited to the area of scan bodies Assessment of the root man square RMS deviations will be the primary outcome The effect of the type of edentulous jaw maxilla vs mandible on the 3D deviations will be the secondary outcome assessing whether the jaw has an effect on the amount of 3D deviations
Prostheses fabrication The final restorative phase included definitive with one-piece screw-retained zirconia implant-supported prostheses The prosthesis will be constructed from the most accurate workflow after confirmation of the passive fit at the try-in appointment In addition the fit of the zirconia implant-supported prostheses will be confirmed prior to delivery clinically and radiographically
Statistical analysis Statistical analysis will be performed by SPSS version 29 IBM Corp Armonk NY Data will be presented as mean median and standard deviation The normality of data will be tested by the Shapiro-Wilk test The generalized linear mixed model will be used to compare the influence of scan bodies and impression copings on the accuracy of digital and conventional impressions The fixed factors will be the IOS type of scan body type of impression coping and their interaction The precision will be calculated using the gamma distribution with the log-link function The p values will be adjusted by the Bonferroni method for pairwise comparison 05
All clinical outcomes will be assessed by one examiner Since some patients will received more than one implant linear mixed effect models LMM will be fitted using restricted maximum likelihood estimations to assess the effect of the follow-up time on repeated measurements of marginal bone loss plaque index calculus index gingival index bleeding index and probing depth while accounting for within-person variability LMM calculates means with standard errors as it estimates variability across multiple samples of a population ie the different patients implants and repeated measures The multivariable models included the fixed effects of the baseline value and follow-up in months The interaction between the baseline and follow-up value baseline valuefollow-up will be tested for model improvement The included random effect will be the patient ie random intercepts The random effect of the follow-up ie random slopes will be also tested Statistical comparisons will be performed using the type III analysis of variance test with Satterthwaites method to estimate the degrees of freedom A significance level of p 005 will be chosen for all the analyses
Study design The ethical approval will be obtained from the research ethics board Thirty edentulous patients who received 4 - 6 implant and indicated for implant-supported fixed prosthesis will be invited All participants will require to read and sign the informed consent form before initiation of the treatment The impression procedures will be performed by one experienced prosthodontist The prostheses will be evaluated by an independent prosthodontist
Sample size calculation The sample size is calculated based on the tests for paired means With α 005 β 02 mean of distance deviation IOS 17 μm and standard deviation 34 μm a sample size of 25 is necessary which would have the power of 90 to detect the difference Therefore a total of 25 patients will be invited to participate in this clinical study This sample size is more than previous studies evaluating IOS and SPG workflows 15 - 17 patients However it has been reported that the dropout rate in clinical studies is 20 For this reason a total of 30 patients will be invited to compensate for the anticipated loss of patients
Treatment procedure Conventional impression Abutment-level impression copings will hand tightened onto the abutments and splinted with autopolymerizing acrylic resin Pattern Resin GC and allowed to polymerize A custom open-tray splinted impressions will be made with a polyether material Impregum Penta Soft 3M ESPE After 5 minutes the impression copings will be unscrewed from the implants and the impression will be removed Type IV dental stone dentostone 220 dentona AG will be poured into the impression to generate a definitive cast The models will be digitalized with a high-resolution laboratory scanner E4 3Shape AS with an accuracy of 4 mm to obtain the 3D data of the models in standard tessellation language STL format
Digital impressions After tightening the scan bodies CARES RC Mono Scan body Straumann Basel Switzerland the intraoral scanner will be used according to the manufacturers recommendations Three scanners will be used since they have different ways of obtaining 3D images and working principles The technology of Trios scanner TRIOS 4 3Shape AS depends on confocal microscopy ultrafast optical scanning and auto-correction Cerec Primescan Dentsply Sirona depends on optical triangulation and confocal microscopy Medit i700 Medit Seoul Korea depends on 3D in-motion video technology 3D full-color streaming capture and advance algorithm to stitch images The scanning path will begin with the occlusal surfaces then turned to the palatal or lingual surfaces and lastly to the buccal surfaces of the scan bodies Then removing the scan body with a trim tool from the occlusal view and exporting the STL file
Accuracy measurement All STL files generated from the intraoral scan STL digital and the STL files generated from cast digitization STL conventional will be imported into 3D inspection software Geomagic 3D Systems Inc Rock Hill SC for merging and evaluation of 3D deviations Following software best-fit alignment the 3D comparison will be used to evaluate the 3D deviations between the digital files STL files from IOS and digitized conventional working casts limited to the area of scan bodies Assessment of the root man square RMS deviations will be the primary outcome The effect of the type of edentulous jaw maxilla vs mandible on the 3D deviations will be the secondary outcome assessing whether the jaw has an effect on the amount of 3D deviations
Prostheses fabrication The final restorative phase included definitive with one-piece screw-retained zirconia implant-supported prostheses The prosthesis will be constructed from the most accurate workflow after confirmation of the passive fit at the try-in appointment In addition the fit of the zirconia implant-supported prostheses will be confirmed prior to delivery clinically and radiographically
Statistical analysis Statistical analysis will be performed by SPSS version 29 IBM Corp Armonk NY Data will be presented as mean median and standard deviation The normality of data will be tested by the Shapiro-Wilk test The generalized linear mixed model will be used to compare the influence of scan bodies and impression copings on the accuracy of digital and conventional impressions The fixed factors will be the IOS type of scan body type of impression coping and their interaction The precision will be calculated using the gamma distribution with the log-link function The p values will be adjusted by the Bonferroni method for pairwise comparison 05
All clinical outcomes will be assessed by one examiner Since some patients will received more than one implant linear mixed effect models LMM will be fitted using restricted maximum likelihood estimations to assess the effect of the follow-up time on repeated measurements of marginal bone loss plaque index calculus index gingival index bleeding index and probing depth while accounting for within-person variability LMM calculates means with standard errors as it estimates variability across multiple samples of a population ie the different patients implants and repeated measures The multivariable models included the fixed effects of the baseline value and follow-up in months The interaction between the baseline and follow-up value baseline valuefollow-up will be tested for model improvement The included random effect will be the patient ie random intercepts The random effect of the follow-up ie random slopes will be also tested Statistical comparisons will be performed using the type III analysis of variance test with Satterthwaites method to estimate the degrees of freedom A significance level of p 005 will be chosen for all the analyses
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