Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575803
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Recycling of Three Pressable Ceramics With Different Weight Percentage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Repressing of Three Pressable Ceramics With Different Weight Percentage on Patient Satisfaction Microstructure and Biaxial Flexural Strength
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Green dentistry is high-technology approach that reduces the environmental impact of dental practices improper disposal of dental materials wastes results in environmental hazards
Aim of the study This studied will be performed o evaluate the effect of repressing of three different types of pressable ceramics Ips Emax press Lisi press and Celtra press with different weight percentages on patient satisfaction mechanical properties microstructural features and composition of these pressable ceramics
Materials Methods
Seventy five N75 pressable ceramic discs will be constructed The samples will be divided to three groups n25 each according to types and composition of pressed and repressed ceramics Group 1 IPS Emax press Group 2 Gc Lisipress Group 3 Celtrapress Each group willbe divided into 5 sub-groups n5 according to the weight percentage of newly pressed and repressed ceramics Subgroup A 100 new ceramics Subgroup B 75 new and 25 repressed ceramic Subgroup C 50 new and 50 repressed ceramics Subgroup D25new and 75 repressed ceramics Subgroup E 100 repressed ceramics Biaxial flexural strength will be measured using universal testing machine X-ray diffraction will be performed to identify the crystalline phases and a scanning electron microscope will be used to describe microstructural features Energy dispersive X-ray analysis will be used to evaluate change in composition Also surface hardness will be evaluated Patient satisfaction plaque cervical caries and marginal discoloration will be evaluated in a follow- up of one year in vivo part
Aim of the study This studied will be performed o evaluate the effect of repressing of three different types of pressable ceramics Ips Emax press Lisi press and Celtra press with different weight percentages on patient satisfaction mechanical properties microstructural features and composition of these pressable ceramics
Materials Methods
Seventy five N75 pressable ceramic discs will be constructed The samples will be divided to three groups n25 each according to types and composition of pressed and repressed ceramics Group 1 IPS Emax press Group 2 Gc Lisipress Group 3 Celtrapress Each group willbe divided into 5 sub-groups n5 according to the weight percentage of newly pressed and repressed ceramics Subgroup A 100 new ceramics Subgroup B 75 new and 25 repressed ceramic Subgroup C 50 new and 50 repressed ceramics Subgroup D25new and 75 repressed ceramics Subgroup E 100 repressed ceramics Biaxial flexural strength will be measured using universal testing machine X-ray diffraction will be performed to identify the crystalline phases and a scanning electron microscope will be used to describe microstructural features Energy dispersive X-ray analysis will be used to evaluate change in composition Also surface hardness will be evaluated Patient satisfaction plaque cervical caries and marginal discoloration will be evaluated in a follow- up of one year in vivo part
Detailed Description:
Methods
This study will be divided into two parts I In vitro and in vivo studies
In vitro study
1 Sample size calculation
2 Sample grouping
3 Fabrication of the ceramic discs
4 Testing procedures
5 Statistical analysis
Sample size estimation and statistical power
ANOVA test was used according to a previous study by Salem et al 2019 15 the mean values for the fracture strength ranged from 819366N to 929724 according to the weight percentage of the newly pressed and repressed ceramics G power statistical power analysis program version 3192 will be used for sample size calculation A total sample size of75 3groups with 5 subgroups 5 sample in each sub group will be sufficient to detect a large effect size of 052 with an actual power 1-β error of 09595 and a significance level αerror 005 5 for two-sided hypothesis test
Sample preparation In this study pressable and repressable ceramic discs will be fabricated Lost wax technique will be used to manufacture disc-shaped ceramic specimens of three types of pressable ceramic
Sample grouping
A total of seventy five N75 pressable ceramic discs will be fabricated The samples will be divided to three groups n25 each according types and composition of pressable ceramics that will be used
Group 1 IPS emax press pressed and repressed n25 Group 2 Gc Lisipress pressed and repressed n25 Group 3 Celtrapress Pressed and repressed n25 Each group will be divided into 5 sub-groups n5 according to the weight percentage of newly pressed and repressed ceramics Subgroup A Samples will be 100 new ceramics Subgroup B Samples will be 75 new and 25 repressed ceramic Subgroup C Samples will be 50 new and 50 repressed ceramics Subgroup D samples will be 25 new and 75 repressed ceramics Subgroup E Samples will be100 repressed ceramics Fabrication of the ceramic discs 3D printed resin specimens will be sprued and invested in a ring system using phosphate bonded investment The ring will be then placed in a burnout furnace Ceramic ingots will be plasticized and pressed in its softened state into the hollow place in the investment ring by means of a plunger After pressing the pressed discs and sprues will be weighed to calculate the needed weight of ceramic needed for fabrication of the samples The sprues will be cutThe ceramic that will be repressed will be placed into the opening at the top surface of the investment mold Ceramic material will be placed in each pressing cycle according to the desired Wt of pressed and repressed ceramics
Laboratory steps
Fabrication of pressed and repressed ceramic discs
1 Construction of resin patterns
2 Spruing of resin patterns
3 Investing of resin patterns
4 Resin elimination
5 Pressing
6 Divesting
7 Finishing and polishing of the discs
Construction of the resin patterns
A digital design of the disc-shaped specimen ten millimeters in diameter and one and half millimeter in thickness will be designed by computer-aided design software The specimen design will be printed by a 3d printer Seventy-five resin disc specimens will be produced
Spruing of resin patterns
3d printed resin patterns will be sprued following the manufacturer instructions
Pressing
1 Ceramic material will placed in each pressing cycle according to the desired Wt of pressed and repressed
Resin elimination
Resin will be eliminated according to manufacturer recommendations the investment ring was placed in the burn out furnace
Divesting
The length of the plunger will be marked on the cold investment ring then The ring will be separated using a separating disc Finishing and polishing of the discs Ceramic discs will be finished according to the manufacturers instructions and polished
Thermo mechanical aging
Ceramic disc specimens will be subjected to thermo-mechanical aging thermocycling and cyclic loading using chewing simulator integrated with thermocycling protocol to simulate a total of 6 months of clinical chewing conditions
Testing procedure
Flexural strength will be measured using universal testing machine Vicker hardness and fracture toughness will be determined by indentation technique
Scanning electron microscope will be used to evaluate microstructure of pressed and repressed ceramics X-ray diffraction will be used to evaluate the crystalline phase Energy dispersive X-ray analysis EDAX will be used to evaluate change in composition of pressed and repressed ceramic
Scanning electron microscope will be used to evaluate microstructure of pressed and repressed ceramics In vivo part II Case presentation for the groups All the groups and sub-groups in the vitro part will be evaluated as a case presentation study
Part I In vivo study
Following randomized clinical trial rules 1 Ethical considerations 2 Patient selection 3 Pre-operative phase 4 Operative phase 5 Laboratory steps 6 Cementation 7 Clinical evaluation
Ethical considerations
The study proposal was approved by the Research Ethics Committee REC of the Faculty of Dental Medicine for girls Al-Azhar University under code Code of approval P-CR-24-02
Patients will be informed about the characteristics and aim of the study and will sign an Informed consent
Subject and selection criteria
This study will be conducted on the patient who need single crowns attending the outpatient clinic of the Crowns and Bridges department Faculty of Dental Medicine for Girls Al-Azhar University
This study will be conducted after obtaining the approval of Research Ethic Committee RECFaculty of Dental Medicine for Girls Al-Azhar University
The entire patients will be informed about the purpose of investigation clinical procedures benefits and hazards of the applied materials and procedure Before initiation of the procedure a written informed consent will be signed by the patients Inclusion Criteria
Patients requesting single crowns for mandibular posterior teeth
Mandibular posterior teeth that will be prepared to receive single crowns should have adequate crown root ratio periodontal support exhibited minimal mobility and adequate tooth preparation length to ensure proper resistance and retention form
Cooperative patients Exclusion Criteria Patients with severe periodontitis gingival inflammation parafunction and poor oral hygiene or high caries activity will be excluded from the present study
Pre- operative phase
A complete case history including chief complain personal data dental and medical history will be taken orally from each patient
Also periapical radiograph of abutment tooth and pre-operative clinical examination will be performed for each patient
Diagnostic casts of the maxillary and mandibular arches will be obtained after pouring alginate impression
Operative phase
A Preparation B Secondary impression C Samples grouping
Preparation
Clinical procedures will be performed on either vital or endodontically treated molars
Secondary impression
Impression will be taken for each case using Addition silicone impression material and will be poured with type V dental stone
Samples grouping
Patients will be divided into 3 groups according to types and composition of pressable ceramics that will be used Group 1 IPS emax press pressed and repressed Group 2 Gc Lisipress pressed and repressed Group 3 Celtrapress pressed and repressed Each group will be divided into 5 sub-groups according to the weight percentage of newly pressed and repressed ceramics Subgroup A Samples will be 100 new ceramics Subgroup B Samples will be 75 new and 25 repressed ceramic Subgroup C Samples will be 50 new and 50 repressed ceramics Subgroup D Samples will be 25 new and 75 repressed ceramics Subgroup E Samples will be 100 repressed ceramics
Laboratory steps
Fabrication of pressed ceramic crowns subgroup A
1 Construction of wax patterns 2 Spruing of wax patterns 3 Investing of wax patterns 4 Wax elimination 5 Pressing 6 Divesting 7 Finishing and glazing
Construction of the wax patterns
The wax patterns will be constructed using CADCAM system
The CADCAM system include the following
Acquisition unit that consists of
1 A desktop computer connected to Dental Scanner
2 Exocad computer software that is responsible for designing the restoration then imports an STL file to the milling machine
Milling Machine Wax discs will be milled
Spruing of wax patterns
Following the manufacturer instructions milled wax patterns will be sprued
Pressing
Ceramic material will placed in each pressing cycle according to the desired Wt of pressed and repressed ceramics
Wax elimination
Wax will be eliminated according to manufacturer recommendations the investment ring was placed in the burn out furnace
Divesting
The length of the plunger will be marked on the cold investment ring then the ring will be separated using a separating disc
Finishing and glazing of restorations
According to the manufacturers instructions all crowns will be finished and glazed
Cementation
The single crowns will be cemented in patient mouth
Clinical evaluation
Clinical performance of all crowns of the studied subgroups in terms of marginal discoloration color stability fracture patient satisfaction will be evaluated at base line 1week 3 and 6 months after cementation
Clinical evaluation will be performed according to
Modified United States Health Service USPHS Ryge Criteria at base line 1 week 3 6 and 12 months after cementation
The presence of plaque will be evaluated using the Loe and Silness plaque index
Clinical examination will be performed using a mirror and sharp explorer radiograph and photograph
Patient satisfaction will be evaluated using a questionnaire
The patient satisfaction
Patient satisfaction of each subgroup will be assessed by using Visual Analogue Scale VAS which is documented chart in the form of satisfied or unsatisfied A questionnaire will be used to evaluate restorations at baseline 1 week after cementation 3 and 6 months
This study will be divided into two parts I In vitro and in vivo studies
In vitro study
1 Sample size calculation
2 Sample grouping
3 Fabrication of the ceramic discs
4 Testing procedures
5 Statistical analysis
Sample size estimation and statistical power
ANOVA test was used according to a previous study by Salem et al 2019 15 the mean values for the fracture strength ranged from 819366N to 929724 according to the weight percentage of the newly pressed and repressed ceramics G power statistical power analysis program version 3192 will be used for sample size calculation A total sample size of75 3groups with 5 subgroups 5 sample in each sub group will be sufficient to detect a large effect size of 052 with an actual power 1-β error of 09595 and a significance level αerror 005 5 for two-sided hypothesis test
Sample preparation In this study pressable and repressable ceramic discs will be fabricated Lost wax technique will be used to manufacture disc-shaped ceramic specimens of three types of pressable ceramic
Sample grouping
A total of seventy five N75 pressable ceramic discs will be fabricated The samples will be divided to three groups n25 each according types and composition of pressable ceramics that will be used
Group 1 IPS emax press pressed and repressed n25 Group 2 Gc Lisipress pressed and repressed n25 Group 3 Celtrapress Pressed and repressed n25 Each group will be divided into 5 sub-groups n5 according to the weight percentage of newly pressed and repressed ceramics Subgroup A Samples will be 100 new ceramics Subgroup B Samples will be 75 new and 25 repressed ceramic Subgroup C Samples will be 50 new and 50 repressed ceramics Subgroup D samples will be 25 new and 75 repressed ceramics Subgroup E Samples will be100 repressed ceramics Fabrication of the ceramic discs 3D printed resin specimens will be sprued and invested in a ring system using phosphate bonded investment The ring will be then placed in a burnout furnace Ceramic ingots will be plasticized and pressed in its softened state into the hollow place in the investment ring by means of a plunger After pressing the pressed discs and sprues will be weighed to calculate the needed weight of ceramic needed for fabrication of the samples The sprues will be cutThe ceramic that will be repressed will be placed into the opening at the top surface of the investment mold Ceramic material will be placed in each pressing cycle according to the desired Wt of pressed and repressed ceramics
Laboratory steps
Fabrication of pressed and repressed ceramic discs
1 Construction of resin patterns
2 Spruing of resin patterns
3 Investing of resin patterns
4 Resin elimination
5 Pressing
6 Divesting
7 Finishing and polishing of the discs
Construction of the resin patterns
A digital design of the disc-shaped specimen ten millimeters in diameter and one and half millimeter in thickness will be designed by computer-aided design software The specimen design will be printed by a 3d printer Seventy-five resin disc specimens will be produced
Spruing of resin patterns
3d printed resin patterns will be sprued following the manufacturer instructions
Pressing
1 Ceramic material will placed in each pressing cycle according to the desired Wt of pressed and repressed
Resin elimination
Resin will be eliminated according to manufacturer recommendations the investment ring was placed in the burn out furnace
Divesting
The length of the plunger will be marked on the cold investment ring then The ring will be separated using a separating disc Finishing and polishing of the discs Ceramic discs will be finished according to the manufacturers instructions and polished
Thermo mechanical aging
Ceramic disc specimens will be subjected to thermo-mechanical aging thermocycling and cyclic loading using chewing simulator integrated with thermocycling protocol to simulate a total of 6 months of clinical chewing conditions
Testing procedure
Flexural strength will be measured using universal testing machine Vicker hardness and fracture toughness will be determined by indentation technique
Scanning electron microscope will be used to evaluate microstructure of pressed and repressed ceramics X-ray diffraction will be used to evaluate the crystalline phase Energy dispersive X-ray analysis EDAX will be used to evaluate change in composition of pressed and repressed ceramic
Scanning electron microscope will be used to evaluate microstructure of pressed and repressed ceramics In vivo part II Case presentation for the groups All the groups and sub-groups in the vitro part will be evaluated as a case presentation study
Part I In vivo study
Following randomized clinical trial rules 1 Ethical considerations 2 Patient selection 3 Pre-operative phase 4 Operative phase 5 Laboratory steps 6 Cementation 7 Clinical evaluation
Ethical considerations
The study proposal was approved by the Research Ethics Committee REC of the Faculty of Dental Medicine for girls Al-Azhar University under code Code of approval P-CR-24-02
Patients will be informed about the characteristics and aim of the study and will sign an Informed consent
Subject and selection criteria
This study will be conducted on the patient who need single crowns attending the outpatient clinic of the Crowns and Bridges department Faculty of Dental Medicine for Girls Al-Azhar University
This study will be conducted after obtaining the approval of Research Ethic Committee RECFaculty of Dental Medicine for Girls Al-Azhar University
The entire patients will be informed about the purpose of investigation clinical procedures benefits and hazards of the applied materials and procedure Before initiation of the procedure a written informed consent will be signed by the patients Inclusion Criteria
Patients requesting single crowns for mandibular posterior teeth
Mandibular posterior teeth that will be prepared to receive single crowns should have adequate crown root ratio periodontal support exhibited minimal mobility and adequate tooth preparation length to ensure proper resistance and retention form
Cooperative patients Exclusion Criteria Patients with severe periodontitis gingival inflammation parafunction and poor oral hygiene or high caries activity will be excluded from the present study
Pre- operative phase
A complete case history including chief complain personal data dental and medical history will be taken orally from each patient
Also periapical radiograph of abutment tooth and pre-operative clinical examination will be performed for each patient
Diagnostic casts of the maxillary and mandibular arches will be obtained after pouring alginate impression
Operative phase
A Preparation B Secondary impression C Samples grouping
Preparation
Clinical procedures will be performed on either vital or endodontically treated molars
Secondary impression
Impression will be taken for each case using Addition silicone impression material and will be poured with type V dental stone
Samples grouping
Patients will be divided into 3 groups according to types and composition of pressable ceramics that will be used Group 1 IPS emax press pressed and repressed Group 2 Gc Lisipress pressed and repressed Group 3 Celtrapress pressed and repressed Each group will be divided into 5 sub-groups according to the weight percentage of newly pressed and repressed ceramics Subgroup A Samples will be 100 new ceramics Subgroup B Samples will be 75 new and 25 repressed ceramic Subgroup C Samples will be 50 new and 50 repressed ceramics Subgroup D Samples will be 25 new and 75 repressed ceramics Subgroup E Samples will be 100 repressed ceramics
Laboratory steps
Fabrication of pressed ceramic crowns subgroup A
1 Construction of wax patterns 2 Spruing of wax patterns 3 Investing of wax patterns 4 Wax elimination 5 Pressing 6 Divesting 7 Finishing and glazing
Construction of the wax patterns
The wax patterns will be constructed using CADCAM system
The CADCAM system include the following
Acquisition unit that consists of
1 A desktop computer connected to Dental Scanner
2 Exocad computer software that is responsible for designing the restoration then imports an STL file to the milling machine
Milling Machine Wax discs will be milled
Spruing of wax patterns
Following the manufacturer instructions milled wax patterns will be sprued
Pressing
Ceramic material will placed in each pressing cycle according to the desired Wt of pressed and repressed ceramics
Wax elimination
Wax will be eliminated according to manufacturer recommendations the investment ring was placed in the burn out furnace
Divesting
The length of the plunger will be marked on the cold investment ring then the ring will be separated using a separating disc
Finishing and glazing of restorations
According to the manufacturers instructions all crowns will be finished and glazed
Cementation
The single crowns will be cemented in patient mouth
Clinical evaluation
Clinical performance of all crowns of the studied subgroups in terms of marginal discoloration color stability fracture patient satisfaction will be evaluated at base line 1week 3 and 6 months after cementation
Clinical evaluation will be performed according to
Modified United States Health Service USPHS Ryge Criteria at base line 1 week 3 6 and 12 months after cementation
The presence of plaque will be evaluated using the Loe and Silness plaque index
Clinical examination will be performed using a mirror and sharp explorer radiograph and photograph
Patient satisfaction will be evaluated using a questionnaire
The patient satisfaction
Patient satisfaction of each subgroup will be assessed by using Visual Analogue Scale VAS which is documented chart in the form of satisfied or unsatisfied A questionnaire will be used to evaluate restorations at baseline 1 week after cementation 3 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None