Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748379
Status:
RECRUITING
Last Update Posted:
2023-02-28
First Post:
2023-01-11
Brief Title:
Atraumatic Zirconia Abutment Versus Customized Composite Healing Abutment in Maxilla or Mandible
Sponsor:
SIA Adenta
Organization:
SIA Adenta
Study Overview
Official Title:
Closure of a Guided Immediate Implant Placed in the Extraction Socket With Bone Augmentation in the Lateral Area of the Maxilla or Mandible With a Temporary Composite Abutment vs With a Custom-made Zirconium Oxide Abutment
Status:
RECRUITING
Status Verified Date:
2023-02
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:
40 patients are included in the study 20 patients in group 1 closure with composite material shaper test group and 20 patients in group 2 closure with custom-made zirconia oxide abutment control group
Randomisation envelopes will be used for randomisation Device under study Straumann BLX Roxolid SLActive dental implants with a diameter of 35 375 4 45 mm are used
Allogenic bone botiss maxgraft cortical granules are used as graft material
Inclusion criteria
1 Males and females at least 18 years of age or older
2 One implant per patient
3 Prior to any study-related activity the subject must voluntarily sign informed consent be willing and able to attend scheduled follow-up visits and agree to the collection and analysis of pseudonymised data
4 Lateral individual teeth premolars and molars
5 Class I extraction socket intact buccal wall or class II 13 of buccal wall
6 The gingival contour of the tooth to be extracted - without recession
7 Adjacent anterior teeth have no periodontal loss
8 There are no implants in the adjacent teeth
9 Non-traumatic tooth extraction which results in intact walls of the socket
Exclusion criteria
1 Deep occlusion severe class II
2 The patient smokes a lot more than 10 cigarettes per day
3 Systemic disease osteoporosis
4 No initial stability has been achieved after the implant insertion procedure
Randomisation envelopes will be used for randomisation Device under study Straumann BLX Roxolid SLActive dental implants with a diameter of 35 375 4 45 mm are used
Allogenic bone botiss maxgraft cortical granules are used as graft material
Inclusion criteria
1 Males and females at least 18 years of age or older
2 One implant per patient
3 Prior to any study-related activity the subject must voluntarily sign informed consent be willing and able to attend scheduled follow-up visits and agree to the collection and analysis of pseudonymised data
4 Lateral individual teeth premolars and molars
5 Class I extraction socket intact buccal wall or class II 13 of buccal wall
6 The gingival contour of the tooth to be extracted - without recession
7 Adjacent anterior teeth have no periodontal loss
8 There are no implants in the adjacent teeth
9 Non-traumatic tooth extraction which results in intact walls of the socket
Exclusion criteria
1 Deep occlusion severe class II
2 The patient smokes a lot more than 10 cigarettes per day
3 Systemic disease osteoporosis
4 No initial stability has been achieved after the implant insertion procedure
Detailed Description:
General Notes
40 patients are included in the study 20 patients in group 1 closure with composite material shaper test group and 20 patients in group 2 closure with custom-made zirconia oxide abutment control group
Randomisation envelopes will be used for randomisation Device under study Straumann BLX Roxolid SLActive dental implants with a diameter of 35 375 4 45 mm are used
Allogenic bone botiss maxgraft cortical granules are used as graft material
Inclusion criteria
1 Males and females at least 18 years of age or older
2 One implant per patient
3 Prior to any study-related activity the subject must voluntarily sign informed consent be willing and able to attend scheduled follow-up visits and agree to the collection and analysis of pseudonymised data
4 Lateral individual teeth premolars and molars
5 Class I extraction socket intact buccal wall or class II 13 of buccal wall
6 The gingival contour of the tooth to be extracted - without recession
7 Adjacent anterior teeth have no periodontal loss
8 There are no implants in the adjacent teeth
9 Non-traumatic tooth extraction which results in intact walls of the socket
Exclusion criteria
1 Deep occlusion severe class II
2 The patient smokes a lot more than 10 cigarettes per day
3 Systemic disease osteoporosis
4 No initial stability has been achieved after the implant insertion procedure 42 Surgical Procedures and Recovery Phase see Annexes No 1 and 2
Group 1 Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone
1 Non-traumatic extraction
2 Palatal position of tapered implant for premolars and centred position for molars more commonly - in the septum 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance
3 For premolars the implant is placed palatally 2-3 mm to the buccal bone wall for molars 2-3 mm to the buccal and lingual wall
4 Implant insertion
5 Jump distance sealing with allogeneic bone
6 Temporary closure with a composite shaper
7 Cone beam computed tomography with Carestream machine
8 Taking a photo
9 Scan with 3Shape TRIOS4 scanner
After 3 months a cone beam computed tomography is performed to evaluate changes in the crestal bone the temporary restoration is screwed off and the presenceabsence of bleeding is recorded A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate Both measurements will be taken using CBCT one immediately after the surgery and the other one 3 month later
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability Measurements will be taken before immediately after the surgery and 3 month later By using STL files it will be possible to compare soft tissue stability
Group 2 Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone
1 Non-traumatic extraction
2 Palatal position of tapered implant for premolars and centred position for molars more commonly - in the septum 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance
3 For premolars the implant is placed palatally 2-3 mm to the buccal bone wall for molars 2-3 mm to the buccal and lingual wall
4 Implant insertion
5 Jump distance sealing with allogeneic bone
6 Closure with a zirconium oxide abutment
7 Cone beam computed tomography with Carestream machine
8 Taking a photo
9 Scan with 3Shape TRIOS4 scanner
After 3 months a cone beam computed tomography is performed to evaluate changes in the crestal bone the custom-made abutment is screwed off and the presenceabsence of bleeding is recorded A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate Both measurements will be taken using CBCT one immediately after the surgery and the other one 3 month later
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability Measurements will be taken before immediately after the surgery and 3 month later By using STL files it will be possible to compare soft tissue stability
Evaluation Phase
T1 Basic After the performance of final restoration X-ray photograph scan PD BOP RI
T2 Follow-up after 3 months X-ray photograph scan PD BOP RI T3 Follow-up after a year X-ray photograph scan PD BOP RI
40 patients are included in the study 20 patients in group 1 closure with composite material shaper test group and 20 patients in group 2 closure with custom-made zirconia oxide abutment control group
Randomisation envelopes will be used for randomisation Device under study Straumann BLX Roxolid SLActive dental implants with a diameter of 35 375 4 45 mm are used
Allogenic bone botiss maxgraft cortical granules are used as graft material
Inclusion criteria
1 Males and females at least 18 years of age or older
2 One implant per patient
3 Prior to any study-related activity the subject must voluntarily sign informed consent be willing and able to attend scheduled follow-up visits and agree to the collection and analysis of pseudonymised data
4 Lateral individual teeth premolars and molars
5 Class I extraction socket intact buccal wall or class II 13 of buccal wall
6 The gingival contour of the tooth to be extracted - without recession
7 Adjacent anterior teeth have no periodontal loss
8 There are no implants in the adjacent teeth
9 Non-traumatic tooth extraction which results in intact walls of the socket
Exclusion criteria
1 Deep occlusion severe class II
2 The patient smokes a lot more than 10 cigarettes per day
3 Systemic disease osteoporosis
4 No initial stability has been achieved after the implant insertion procedure 42 Surgical Procedures and Recovery Phase see Annexes No 1 and 2
Group 1 Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone
1 Non-traumatic extraction
2 Palatal position of tapered implant for premolars and centred position for molars more commonly - in the septum 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance
3 For premolars the implant is placed palatally 2-3 mm to the buccal bone wall for molars 2-3 mm to the buccal and lingual wall
4 Implant insertion
5 Jump distance sealing with allogeneic bone
6 Temporary closure with a composite shaper
7 Cone beam computed tomography with Carestream machine
8 Taking a photo
9 Scan with 3Shape TRIOS4 scanner
After 3 months a cone beam computed tomography is performed to evaluate changes in the crestal bone the temporary restoration is screwed off and the presenceabsence of bleeding is recorded A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate Both measurements will be taken using CBCT one immediately after the surgery and the other one 3 month later
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability Measurements will be taken before immediately after the surgery and 3 month later By using STL files it will be possible to compare soft tissue stability
Group 2 Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone
1 Non-traumatic extraction
2 Palatal position of tapered implant for premolars and centred position for molars more commonly - in the septum 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance
3 For premolars the implant is placed palatally 2-3 mm to the buccal bone wall for molars 2-3 mm to the buccal and lingual wall
4 Implant insertion
5 Jump distance sealing with allogeneic bone
6 Closure with a zirconium oxide abutment
7 Cone beam computed tomography with Carestream machine
8 Taking a photo
9 Scan with 3Shape TRIOS4 scanner
After 3 months a cone beam computed tomography is performed to evaluate changes in the crestal bone the custom-made abutment is screwed off and the presenceabsence of bleeding is recorded A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes
The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest
While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate Both measurements will be taken using CBCT one immediately after the surgery and the other one 3 month later
Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability Measurements will be taken before immediately after the surgery and 3 month later By using STL files it will be possible to compare soft tissue stability
Evaluation Phase
T1 Basic After the performance of final restoration X-ray photograph scan PD BOP RI
T2 Follow-up after 3 months X-ray photograph scan PD BOP RI T3 Follow-up after a year X-ray photograph scan PD BOP RI
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