Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06460103 |
Other study ID # |
AP2022-06 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2024 |
Est. completion date |
December 2027 |
Study information
Verified date |
June 2024 |
Source |
University Hospital, Geneva |
Contact |
Alexandre Perez, Dr |
Phone |
+4179 553 50 41 |
Email |
alexandre.perez[@]hug.ch |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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, i.e.
hydrophilicity, affect the osseointegration of the implant in simultaneously augmented bone.
The secondary objective is to assess if implant surface properties, i.e. 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.
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, e.g. long-term
mechanical and aesthetic stability of load-bearing dental implants. Implant integration in
simultaneously augmented bone, i.e. 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 surface/bone 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 study's 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, i.e. a permanent implant-born restoration, is not expected to be affected by the
planned investigation-related intervention, i.e. 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.