Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-28
Brief Title:
Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Effect of Implant Surface Hydrophilicity on Peri-Implant Bone Formation Around Simultaneously Grafted Transiently Placed Titanium Zirconium Dental Small Diameter Implants - A Randomized Controlled Human Histometric Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Although bone grafting at the same time as the placement of dental implants is a common procedure in implantology there are currently no data on the influence of different types of implant surfaces on bone healing which is crucial for implant stability
The primary objective of this study is to assess if implant surface properties ie hydrophilicity affect the osseointegration of the implant in simultaneously augmented bone
The secondary objective is to assess if implant surface properties ie surface hydrophilicity may affect the quantity of newly formed bone in the implant in simultaneously augmented bone
Surface hydrophilicity modification is a well-adapted concept in dental implantology and is clinically well-established
In this prospective study all participants will receive a bone graft after extraction After randomization one group will receive a provisional SLA surface implant and another group will receive a provisional SLActive surface implant The same standard surgical procedure will be performed for both groups when the definitive implant will be placed
The study will run for a total of 3 year and 35 patients per group will be included
The Straumann SLA and SLActive implants Maxgraft allograft and collprotect collagen membranes used in this study are all approved products on the Swiss market
The primary objective of this study is to assess if implant surface properties ie hydrophilicity affect the osseointegration of the implant in simultaneously augmented bone
The secondary objective is to assess if implant surface properties ie surface hydrophilicity may affect the quantity of newly formed bone in the implant in simultaneously augmented bone
Surface hydrophilicity modification is a well-adapted concept in dental implantology and is clinically well-established
In this prospective study all participants will receive a bone graft after extraction After randomization one group will receive a provisional SLA surface implant and another group will receive a provisional SLActive surface implant The same standard surgical procedure will be performed for both groups when the definitive implant will be placed
The study will run for a total of 3 year and 35 patients per group will be included
The Straumann SLA and SLActive implants Maxgraft allograft and collprotect collagen membranes used in this study are all approved products on the Swiss market
Detailed Description:
The proposed study aims to histometrically investigate the influence of Titanium dental implant surface properties on the peri-implant bone formation in simultaneously bone-augmented implantation sites
The magnitude of peri-implant bone formation and implant integration in augmented bone are clinically relevant for various clinical success criteria including eg long-term mechanical and aesthetic stability of load-bearing dental implants Implant integration in simultaneously augmented bone ie the investigated indication can be considered critical for the success of approx 40 to 50 of all performed dental implant procedures world wide The investigated subject is believed to be directly clinically relevant
A common strategy to promote implant osseointegration and long-term implant stability is based on modifying Titanium dental implant surfaces topographical and physicochemical properties
The influence of topographical and physicochemical surface properties including surface energy and hydrophilicity of dental implants on the rate and extend of osseointegration in native bone has been well described Also the physicochemical material characteristics of bone substitutes have been shown to influence the rate of bone formation in augmented sites Despite this thorough understanding of the individual influences of implant and bone graft properties the interaction and synergistic properties between Titanium and Titanium Zirconium dental implant surfaces and bone substitutes on dental implant integration and bone formation in augmented sites remain widely undocumented Investigations on a possible influence of implant surfacebone graft combination on implant osseointegration and peri-implant bone formation remain limited to very defined animal model systems It is currently unclear if the preclinically observed effects may translate and be valid for human subjects Consequently the proposed study hypotheses that implant surface hydrophilicity may influence implant osseointegration and peri-implant bone formation in simultaneously augmented sites is novel clinically undocumented whilst highly relevant for the clinical and aesthetic success of a relevant portion of dental implant procedures
The investigation is planned to be performed in patients displaying single hopeless teeth diagnosed for extraction and replacement by single implants requiring prior bone augmentation at the extraction site The placement and retrieval of mini-implants are not considered to increase the number or significantly impact the type of planned interventions compared to routine treatment
Specifically treatments for the described indication consist of a 2-staged procedure requiring extraction and bone augmentation first stage followed by a second procedure for implant placement second stage The proposed studys design will be based on the placement of a mini implant in the centre of the extraction site as part of the first augmentation procedure The mini-implant placement does not affect the treatment plan or outcome It does not expose the patients to additional risks compared to routine treatment By contrast mini-implant placement may help reduce any potential risks for graft displacement of the bone augmentation and may support bone formation within the augmented area
The second stage procedure will be used to retrieve the mini-implant using a core biopsy trephine instead of preparing the osteotomy by conventional drilling The resulting osteotomy will be subsequently fine-prepared for the final permanent implant placement The required exact placement of the mini-implant at the planned ideal prosthetic position of the final implant can be considered routine is clinically well-plannable and can be well-controlled as part of the available modern treatment workflows The treatment sequence and outcome for the patient ie a permanent implant-born restoration is not expected to be affected by the planned investigation-related intervention ie the placement and retrieval of a mini-implant
From a parametric and methodological standpoint histometric analysis can be considered the method of choice to study and quantify bone-to-implant contact and peri-implant bone formation The patients will be recruited from regular patients diagnosed according to the described indication and scheduled for treatment at the University Hospital of Geneva
The magnitude of peri-implant bone formation and implant integration in augmented bone are clinically relevant for various clinical success criteria including eg long-term mechanical and aesthetic stability of load-bearing dental implants Implant integration in simultaneously augmented bone ie the investigated indication can be considered critical for the success of approx 40 to 50 of all performed dental implant procedures world wide The investigated subject is believed to be directly clinically relevant
A common strategy to promote implant osseointegration and long-term implant stability is based on modifying Titanium dental implant surfaces topographical and physicochemical properties
The influence of topographical and physicochemical surface properties including surface energy and hydrophilicity of dental implants on the rate and extend of osseointegration in native bone has been well described Also the physicochemical material characteristics of bone substitutes have been shown to influence the rate of bone formation in augmented sites Despite this thorough understanding of the individual influences of implant and bone graft properties the interaction and synergistic properties between Titanium and Titanium Zirconium dental implant surfaces and bone substitutes on dental implant integration and bone formation in augmented sites remain widely undocumented Investigations on a possible influence of implant surfacebone graft combination on implant osseointegration and peri-implant bone formation remain limited to very defined animal model systems It is currently unclear if the preclinically observed effects may translate and be valid for human subjects Consequently the proposed study hypotheses that implant surface hydrophilicity may influence implant osseointegration and peri-implant bone formation in simultaneously augmented sites is novel clinically undocumented whilst highly relevant for the clinical and aesthetic success of a relevant portion of dental implant procedures
The investigation is planned to be performed in patients displaying single hopeless teeth diagnosed for extraction and replacement by single implants requiring prior bone augmentation at the extraction site The placement and retrieval of mini-implants are not considered to increase the number or significantly impact the type of planned interventions compared to routine treatment
Specifically treatments for the described indication consist of a 2-staged procedure requiring extraction and bone augmentation first stage followed by a second procedure for implant placement second stage The proposed studys design will be based on the placement of a mini implant in the centre of the extraction site as part of the first augmentation procedure The mini-implant placement does not affect the treatment plan or outcome It does not expose the patients to additional risks compared to routine treatment By contrast mini-implant placement may help reduce any potential risks for graft displacement of the bone augmentation and may support bone formation within the augmented area
The second stage procedure will be used to retrieve the mini-implant using a core biopsy trephine instead of preparing the osteotomy by conventional drilling The resulting osteotomy will be subsequently fine-prepared for the final permanent implant placement The required exact placement of the mini-implant at the planned ideal prosthetic position of the final implant can be considered routine is clinically well-plannable and can be well-controlled as part of the available modern treatment workflows The treatment sequence and outcome for the patient ie a permanent implant-born restoration is not expected to be affected by the planned investigation-related intervention ie the placement and retrieval of a mini-implant
From a parametric and methodological standpoint histometric analysis can be considered the method of choice to study and quantify bone-to-implant contact and peri-implant bone formation The patients will be recruited from regular patients diagnosed according to the described indication and scheduled for treatment at the University Hospital of Geneva
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