Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05409287
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2022-06-03
Brief Title:
Immediate Loading in Single Tooth Implants
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Influence of the Implant Loading Protocol on Implant Survival in Early Placed Single-tooth Implants in Mandibular Posterior Sites Using Computer-assisted Implant Surgery A Randomized Clinical Trial RCT
Status:
RECRUITING
Status Verified Date:
2023-11
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 planned study is designed to provide evidence for the application of early implant placement with partial bone-healing and either an immediate or an early restoration loading protocol
Materials and methods
The study will be conducted according to the recommendations published as the CONSORT statement and respecting the intention to treat principle Participants will be enrolled if they present with a mandibular first molar that has to be extracted and require implant treatment for replacement of the molar Ridge preservation using a well-documented xenogeneic bone substitute will be done following the extraction After 12 weeks of healing a cone-beam computed tomography CBCT and a digital intraoral scan will be taken followed by digital planning of the implant position and the additive construction of a surgical drill guide by means of rapid prototyping using a 3-D printer Afterwards the participants will be randomized into the two study groups
Group A immediate loading A screw-retained PMMA implant provisional bonded to a titanium base will be fabricated subtractively by computer aided design computer aided manufacturing CADCAM based on the data of the digitally planned implant position
Group B early loading No further preparation has to be done
Before finishing 16 weeks post-extraction implants Straumann Standard Implant RN TiZr minimum length 10mm minimum diameter 41mm will be placed in both study groups using sCAIS During surgery the surgeon will not know if the participant was allocated to Group A or Group B Directly after surgery digital intraoral scans will be obtained to record the final implant position Afterwards either the prepared implant provisional Group A immediate loading or a healing cap Group B early loading will be inserted into the implant
4 weeks after implant placement the participants in Group B will receive a loaded screw-retained implant provisional based on the data of the post-surgery scan 6-months after implant placement participants will receive final screw-retained single implant crowns The study end will be a final follow-up visit after 12 months Participants will be invited for further follow-up visits up to 5 years not part of the present proposal Implant survival success will be evaluated according to the criteria described by Buser et al All secondary outcomes will be assessed by validated indices and instruments
Materials and methods
The study will be conducted according to the recommendations published as the CONSORT statement and respecting the intention to treat principle Participants will be enrolled if they present with a mandibular first molar that has to be extracted and require implant treatment for replacement of the molar Ridge preservation using a well-documented xenogeneic bone substitute will be done following the extraction After 12 weeks of healing a cone-beam computed tomography CBCT and a digital intraoral scan will be taken followed by digital planning of the implant position and the additive construction of a surgical drill guide by means of rapid prototyping using a 3-D printer Afterwards the participants will be randomized into the two study groups
Group A immediate loading A screw-retained PMMA implant provisional bonded to a titanium base will be fabricated subtractively by computer aided design computer aided manufacturing CADCAM based on the data of the digitally planned implant position
Group B early loading No further preparation has to be done
Before finishing 16 weeks post-extraction implants Straumann Standard Implant RN TiZr minimum length 10mm minimum diameter 41mm will be placed in both study groups using sCAIS During surgery the surgeon will not know if the participant was allocated to Group A or Group B Directly after surgery digital intraoral scans will be obtained to record the final implant position Afterwards either the prepared implant provisional Group A immediate loading or a healing cap Group B early loading will be inserted into the implant
4 weeks after implant placement the participants in Group B will receive a loaded screw-retained implant provisional based on the data of the post-surgery scan 6-months after implant placement participants will receive final screw-retained single implant crowns The study end will be a final follow-up visit after 12 months Participants will be invited for further follow-up visits up to 5 years not part of the present proposal Implant survival success will be evaluated according to the criteria described by Buser et al All secondary outcomes will be assessed by validated indices and instruments
Detailed Description:
The planned study is designed to provide evidence for the application of early implant placement with partial bone-healing and either an immediate or an early restoration loading protocol
Materials and methods
The study will be conducted according to the recommendations published as the CONSORT statement and respecting the intention to treat principle Participants will be enrolled if they present with a mandibular first molar that has to be extracted and require implant treatment for replacement of the molar Ridge preservation using a well-documented xenogeneic bone substitute will be done following the extraction After 12 weeks of healing a cone-beam computed tomography CBCT and a digital intraoral scan will be taken followed by digital planning of the implant position and the additive construction of a surgical drill guide by means of rapid prototyping using a 3-D printer Afterwards the participants will be randomized into the two study groups
Group A immediate loading A screw-retained PMMA implant provisional bonded to a titanium base will be fabricated subtractively by computer aided design computer aided manufacturing CADCAM based on the data of the digitally planned implant position
Group B early loading No further preparation has to be done
Before finishing 16 weeks post-extraction implants Straumann Standard Implant RN TiZr minimum length 10mm minimum diameter 41mm will be placed in both study groups using sCAIS During surgery the surgeon will not know if the participant was allocated to Group A or Group B Directly after surgery digital intraoral scans will be obtained to record the final implant position Afterwards either the prepared implant provisional Group A immediate loading or a healing cap Group B early loading will be inserted into the implant
4 weeks after implant placement the participants in Group B will receive a loaded screw-retained implant provisional based on the data of the post-surgery scan 6-months after implant placement participants will receive final screw-retained single implant crowns The study end will be a final follow-up visit after 12 months Participants will be invited for further follow-up visits up to 5 years not part of the present proposal Implant survival success will be evaluated according to the criteria described by Buser et al All seconda
Materials and methods
The study will be conducted according to the recommendations published as the CONSORT statement and respecting the intention to treat principle Participants will be enrolled if they present with a mandibular first molar that has to be extracted and require implant treatment for replacement of the molar Ridge preservation using a well-documented xenogeneic bone substitute will be done following the extraction After 12 weeks of healing a cone-beam computed tomography CBCT and a digital intraoral scan will be taken followed by digital planning of the implant position and the additive construction of a surgical drill guide by means of rapid prototyping using a 3-D printer Afterwards the participants will be randomized into the two study groups
Group A immediate loading A screw-retained PMMA implant provisional bonded to a titanium base will be fabricated subtractively by computer aided design computer aided manufacturing CADCAM based on the data of the digitally planned implant position
Group B early loading No further preparation has to be done
Before finishing 16 weeks post-extraction implants Straumann Standard Implant RN TiZr minimum length 10mm minimum diameter 41mm will be placed in both study groups using sCAIS During surgery the surgeon will not know if the participant was allocated to Group A or Group B Directly after surgery digital intraoral scans will be obtained to record the final implant position Afterwards either the prepared implant provisional Group A immediate loading or a healing cap Group B early loading will be inserted into the implant
4 weeks after implant placement the participants in Group B will receive a loaded screw-retained implant provisional based on the data of the post-surgery scan 6-months after implant placement participants will receive final screw-retained single implant crowns The study end will be a final follow-up visit after 12 months Participants will be invited for further follow-up visits up to 5 years not part of the present proposal Implant survival success will be evaluated according to the criteria described by Buser et al All seconda
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