Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05332977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-04-18
First Post:
2022-01-28
Brief Title:
Clinical Study Investigating the Efficiency and Complications Related to Two Different Procedures Used for the Preparation of Dentures Applied in Patients With Edentulous
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Clinical Performance Patient and Operator Reported Outcome Measures of Axially Placed and Tilted Implants Used for Fixed Rehabilitation of the Edentulous Maxilla
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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 principal aim of the study is to evaluate the prosthetic complications with CAD-CAM fabricated provisional prostheses and denture conversion prostheses after 3 months of function Supported restorations are now a predictable treatment modality for the rehabilitation of complete and partially edentulous jawsImmediate loading of the placed implants is performed for the rehabilitation of the edentulous arch to improve patients function This can be usually done by converting the existing denture base of the patient or by making a CAD- CAM milled provisional prosthesis integrating digital workflow A laboratory fabricated denture base can be converted into a screw-retained provisional prosthesis post implant placement This is known as conversion prosthesis However drawbacks of these prostheses include increased chairside time for the clinician leading to inconvenience for the patient and a potential for an error in prosthesis fabrication With the introduction of CAD-CAM technology it is now possible to fabricate a provisional restoration using digital workflows This workflow would help the clinicians save a considerable amount of chairside time and obtain potentially stronger restorations better polished and without contamination of surgical field Studies assessing the soft tissue response and patient-reported outcome measures between denture conversion and CAD- CAM fabricated provisionals are currently lacking in the literature
Detailed Description:
1 Study Intervention and Indication CAD-CAM fabricated provisional prostheses facilitate prosthesis delivery in immediate functional loading protocols The prostheses are manufactured in the laboratory by milling high-density polymers based on a highly cross-linked polymethylmethacrylate PMMA The prostheses are known to have higher biocompatibility superior esthetics and soft tissue response as compared to denture conversion prostheses
The indication is edentulism CAD-CAM fabricated prostheses are implant supported prosthesis and are indicated for rehabilitation of edentulous arch
2 Justification of Study Intervention With the introduction of CAD-CAM technology it is now possible to fabricate a provisional restoration using digital workflows This workflow would help the clinicians to save a considerable amount of chairside time and to obtain potentially stronger restorations better polished and without contamination of surgical field
3 Risk Benefits The participants will be exposed to only minor risks loosening of prosthesis as all procedures used in this study for rehabilitation of the patients have been used in dental clinics The safety and risk profiles are well known Patients will be locally anesthetized during the procedure of implant placement Well-experienced dentists who are very familiar with the procedures and materials used will perform the surgeries On the other hand a significant gain of knowledge will be expected by the use of CAD-CAM fabricated and denture conversion provisional prostheses This will open new insights in respect to rehabilitation of the patients undergoing full arch reconstructions Consequently this will open new therapeutical opportunities in order to provide the best and most adequate treatment strategy for future patients
It is ethically justifiable that the patients included in this study will receive the CAD-CAM fabricated provisional prosthesis as well as the denture conversion prosthesis as this represents todays standard and most often performed procedure
Anticipated adverse effects and residual risks encompass loosening of the prosthesis
4 General Study Design and Justification of the design This study will be designed as monocenter prospective randomized controlled clinical trial with two parallel study groups and a follow-up duration of 5 years after insertion of the final prostheses
Treatment interventions and follow-up
The edentulous patients recruited in the study will be randomized into the following two groups
Placement of tilted implants in the distal most position group-Til with straight implants in the anterior region
Placement of axial implants in the distal most position group-Axl with straight implants in the anterior region
Subjects from the above groups will be further divided into following two sub-groups
Immediate loading using denture conversion prosthesis group DC
Immediate loading using milled PMMA prosthesis group CAD-CAM
5 Methods of Minimising Bias As the implants are clearly distinguishable and require different handling blinding of the surgeon is not feasible
The patients will be given questionnaires and they will be asked to answer them before the start of each visit in absence of the investigator or any study site team member
Additionally the patients are informed about two different procedures for the fabrication of the provisional prosthesis however they are not told about the technical details and which fabrication workflow they have been allocated
The ease of insertion of the provisional prostheses will be evaluated by an evaluator other than the surgeon This evaluator will be the same for both prostheses throughout the study
6 Assignment to Study Group Axial or Tilted implants will be allocated randomly to the patients so that an equal distribution 11 of patients to both treatment groups results Similarly patients will be randomly allocated to group DC and group CAD-CAM prosthesis The randomization sequences will be generated by using a computer-generated list The study manager or the statistician will generate the allocation sequences and will store them with restricted access One randomization will be done by the eCRF after uploading the allocation list and the other randomization will be performed by opening sealed envelopes Whenever an investigator enrolls a patient for the study a subject number ordered number given by the system with a center identification code will be assigned to the patient Subject number will be recorded on the medical record folder of the patient Subject identification Log will enable direct connection to patient identity This list will be filed in a folder with limited access only for study members and will be kept on site
7 Monitoring Institution Due to the minimal risk of the study all treatments are performed according to the standard of care no external monitoring is needed
The quality control will be performed by an internal study monitor of MA Rangoonwala College of Dental Sciences If needed remote monitoring will be performed by the study management team located in Zurich
8 Statistical Methods
Hypothesis
The hypothesises of the present RCT are two-fold
1 There will be no differences in the prosthetic complications of CAD-CAM fabricated provisionals and denture conversion prostheses DC when used as provisional prostheses
2 There will be no difference in the survival rates between tilted and axially placed short implants in distal positions for the rehabilitation of the edentulous maxilla with fixed screw-retained prostheses
Determination of Sample Size Sample size was determined using the percentage of prosthetic complications observed in previous clinical trials using the formula n 2 Zα Zβ2 p1-p d2
where Zα is the z variate of alpha error ie a constant with value 196 Zβ is the z variate of beta error ie a constant with value 084 p is the proportion of events
Approximate estimates
1 80 power
2 Type I error to be 5
3 Type II error to be 20
4 Expected proportion to be 017
5 Least detectable error to be 035 Substituting the values n 2 282 01411 0352
n 1806
To determine the difference in prosthetic complications of CAD-CAM fabricated interim prosthesis as compared to denture conversion prosthesis within 85 of the true value with 95 confidence a sample size of 18 per group was determined alpha005
Approximately 18 subjects per group need to be taken in the present study To cater for 10 drop-outs the sample size was adjusted to 20 per group
9 Planned Analyses
Primary outcomes
The difference in prosthetic complications between the two groups will be compared using Fishers exact test
Secondary Analyses
Secondary outcomes
The difference in implant survival rates will be evaluated using Kaplan-Meier estimation
The difference in technical complications will be analyzed using Fishers exact test and Chi-square test
Inter group comparison 2 groups will be done using t-test for peri-implant biological parameters Probing depth Plaque control record Bleeding on probing marginal bone levels
Patient-reported outcome measures will be analyzed using Chi-Square test
Interim Analyses The primary endpoint is at 3 months after BL and the analysis of the data collected up to those visits will be done No Interim Analysis will be done However further analyses will be done after collection of 1-year data 3- and 5-year data in order to monitor the study outcomes over the time
10 Safety During the entire duration of the study all adverse events AEs serious adverse events SAEs are to be collected fully investigated and documented in source documents and case report forms CRF Study duration encompasses the time from when the participant signs the informed consent until the last investigation plan-specific procedure has been completed
AESAE incidents will be collected at the regular study visits All adverse events will be documented in a timely manner throughout the clinical investigation and reported as specified in ISO 14155 825 and 98
The indication is edentulism CAD-CAM fabricated prostheses are implant supported prosthesis and are indicated for rehabilitation of edentulous arch
2 Justification of Study Intervention With the introduction of CAD-CAM technology it is now possible to fabricate a provisional restoration using digital workflows This workflow would help the clinicians to save a considerable amount of chairside time and to obtain potentially stronger restorations better polished and without contamination of surgical field
3 Risk Benefits The participants will be exposed to only minor risks loosening of prosthesis as all procedures used in this study for rehabilitation of the patients have been used in dental clinics The safety and risk profiles are well known Patients will be locally anesthetized during the procedure of implant placement Well-experienced dentists who are very familiar with the procedures and materials used will perform the surgeries On the other hand a significant gain of knowledge will be expected by the use of CAD-CAM fabricated and denture conversion provisional prostheses This will open new insights in respect to rehabilitation of the patients undergoing full arch reconstructions Consequently this will open new therapeutical opportunities in order to provide the best and most adequate treatment strategy for future patients
It is ethically justifiable that the patients included in this study will receive the CAD-CAM fabricated provisional prosthesis as well as the denture conversion prosthesis as this represents todays standard and most often performed procedure
Anticipated adverse effects and residual risks encompass loosening of the prosthesis
4 General Study Design and Justification of the design This study will be designed as monocenter prospective randomized controlled clinical trial with two parallel study groups and a follow-up duration of 5 years after insertion of the final prostheses
Treatment interventions and follow-up
The edentulous patients recruited in the study will be randomized into the following two groups
Placement of tilted implants in the distal most position group-Til with straight implants in the anterior region
Placement of axial implants in the distal most position group-Axl with straight implants in the anterior region
Subjects from the above groups will be further divided into following two sub-groups
Immediate loading using denture conversion prosthesis group DC
Immediate loading using milled PMMA prosthesis group CAD-CAM
5 Methods of Minimising Bias As the implants are clearly distinguishable and require different handling blinding of the surgeon is not feasible
The patients will be given questionnaires and they will be asked to answer them before the start of each visit in absence of the investigator or any study site team member
Additionally the patients are informed about two different procedures for the fabrication of the provisional prosthesis however they are not told about the technical details and which fabrication workflow they have been allocated
The ease of insertion of the provisional prostheses will be evaluated by an evaluator other than the surgeon This evaluator will be the same for both prostheses throughout the study
6 Assignment to Study Group Axial or Tilted implants will be allocated randomly to the patients so that an equal distribution 11 of patients to both treatment groups results Similarly patients will be randomly allocated to group DC and group CAD-CAM prosthesis The randomization sequences will be generated by using a computer-generated list The study manager or the statistician will generate the allocation sequences and will store them with restricted access One randomization will be done by the eCRF after uploading the allocation list and the other randomization will be performed by opening sealed envelopes Whenever an investigator enrolls a patient for the study a subject number ordered number given by the system with a center identification code will be assigned to the patient Subject number will be recorded on the medical record folder of the patient Subject identification Log will enable direct connection to patient identity This list will be filed in a folder with limited access only for study members and will be kept on site
7 Monitoring Institution Due to the minimal risk of the study all treatments are performed according to the standard of care no external monitoring is needed
The quality control will be performed by an internal study monitor of MA Rangoonwala College of Dental Sciences If needed remote monitoring will be performed by the study management team located in Zurich
8 Statistical Methods
Hypothesis
The hypothesises of the present RCT are two-fold
1 There will be no differences in the prosthetic complications of CAD-CAM fabricated provisionals and denture conversion prostheses DC when used as provisional prostheses
2 There will be no difference in the survival rates between tilted and axially placed short implants in distal positions for the rehabilitation of the edentulous maxilla with fixed screw-retained prostheses
Determination of Sample Size Sample size was determined using the percentage of prosthetic complications observed in previous clinical trials using the formula n 2 Zα Zβ2 p1-p d2
where Zα is the z variate of alpha error ie a constant with value 196 Zβ is the z variate of beta error ie a constant with value 084 p is the proportion of events
Approximate estimates
1 80 power
2 Type I error to be 5
3 Type II error to be 20
4 Expected proportion to be 017
5 Least detectable error to be 035 Substituting the values n 2 282 01411 0352
n 1806
To determine the difference in prosthetic complications of CAD-CAM fabricated interim prosthesis as compared to denture conversion prosthesis within 85 of the true value with 95 confidence a sample size of 18 per group was determined alpha005
Approximately 18 subjects per group need to be taken in the present study To cater for 10 drop-outs the sample size was adjusted to 20 per group
9 Planned Analyses
Primary outcomes
The difference in prosthetic complications between the two groups will be compared using Fishers exact test
Secondary Analyses
Secondary outcomes
The difference in implant survival rates will be evaluated using Kaplan-Meier estimation
The difference in technical complications will be analyzed using Fishers exact test and Chi-square test
Inter group comparison 2 groups will be done using t-test for peri-implant biological parameters Probing depth Plaque control record Bleeding on probing marginal bone levels
Patient-reported outcome measures will be analyzed using Chi-Square test
Interim Analyses The primary endpoint is at 3 months after BL and the analysis of the data collected up to those visits will be done No Interim Analysis will be done However further analyses will be done after collection of 1-year data 3- and 5-year data in order to monitor the study outcomes over the time
10 Safety During the entire duration of the study all adverse events AEs serious adverse events SAEs are to be collected fully investigated and documented in source documents and case report forms CRF Study duration encompasses the time from when the participant signs the informed consent until the last investigation plan-specific procedure has been completed
AESAE incidents will be collected at the regular study visits All adverse events will be documented in a timely manner throughout the clinical investigation and reported as specified in ISO 14155 825 and 98
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