Partially Edentulous MaxillaNCT06460103
Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants
A study testing Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface) and Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface) in people with Partially Edentulous Maxilla and Partially Edentulous Mandible, run by University Hospital, Geneva.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partially Edentulous Maxilla, Partially Edentulous Mandible
- What is being tested?
- Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface) and Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18 years
- Patients with a diagnosed indication for single tooth extraction and scheduled for consented replacement by an implant-based restoration requiring prior bone augmentation
- Only patients displaying periodontally healthy teeth adjacent to the extracted teeth shall be included (probing depth (PD) < 4mm, no bleeding on probing (BOP)
- Patients must be physically and psychologically able to undergo implant surgery and restorative procedures (American Academy of Anesthesiologist class I or II)
Who cannot join
- Presence of any general contra-indication related to implant therapy
- Heavy smokers ( ≥10 cigarettes/day)
- Patients displaying a history of uncontrolled metabolic disorders (e.g. diabetes mellitus)
- Patients with a history of malignancy, radiotherapy, or chemotherapy
- Pregnant or breast feeding patients
- Patients with a history of immunodeficiencies
Show all 11Show fewer
- Patients displaying any metabolic bone disease
- Patients with disturbed bone or wound healing
- Patients with untreated or active periodontitis (BOP and PD>5mm)
- Extraction sites displaying an absent or defections buccal bone plate
- Vulnerable patients will be excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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, 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.
- Being tested
- Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface), Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)
- Keywords
- Dental implants, SLActive, Hydrophile surface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface)Device
Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLActive®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane".
The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation.
Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)Device
Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLA®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane".
The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation.
| Study group | Role | What they receive |
|---|---|---|
| "Straumann® Bone Level Tapered SLActive®" mini-implant (hydrophilic surface) | Experimental | Tooth extraction + "Straumann® Bone Level Tapered, SLActive®" mini-implant placement + bone augmentation (bone graft "maxgraft® cortico-cancellous granules 0.5-2.0mm" and dental membrane "collprotect®membrane") Receives: Device: Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface) |
| "Straumann® Bone Level Tapered implants SLA®" mini-implant (hydrophobic surface) | Active comparator | Tooth extraction + "Straumann® Bone Level Tapered , SLA®" mini-implant placement + bone augmentation (bone graft "maxgraft® cortico-cancellous granules 0.5-2.0mm" and dental membrane "collprotect®membrane") Receives: Device: Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone-to-Implant Contact (BIC)
The cross-sectional implant perimeter percentage in direct contact with newly formed bone over the total cross-sectional implant perimeter. Only the perimeter in contact with augmented bone will be considered for measuring this parameter.
Measured: 3 weeks after implant placement
Secondary outcomes (4)
Percentage of newly formed bone area
The histological cross-sectional area covered by newly formed bone over the total cross-sectional area within a defined region of interest within the augmented sites.
Measured: 3 weeks after implant placement
Graft particle area
The histological cross-sectional area covered by remaining graft particles over the total cross-sectional area within a defined region of interest within the augmented sites.
Measured: 3 weeks after implant placement
Assessment of the tissue inflammatory response
A region of interest within the histological cross-sections of augmented areas will be evaluated with regards to the inflammatory tissue response by quantifying the number of white blood cells to determine the inflammatory score using a standardized four-point scoring scale ranging from "-" for not present to "+++" for markedly present.
Measured: 3 weeks after implant placement
Assessment of the healing response
Vascularization, osteoblasts, and osteoclasts will be scored using a standardized four-point scoring scale ranging from "-" for not present to "+++" for markedly present.This measure will be used to assess the implant surface/bone graft combination's overall healing reaction.
Measured: 3 weeks after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous MaxillaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Perez, University Hospital, Geneva
- Investigators
- Alexandre Perez, Dr, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460103
- Sponsor's protocol ID
- AP2022-06
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06460103
- Acronym / sponsor ID
- AP2022-06
- Keywords
- Dental implants, SLActive, Hydrophile surface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Straumann® Bone Level Tapered SLActive®" mini-implant (hydrophilic surface) | Experimental | Device: Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface)Tooth extraction + "Straumann® Bone Level Tapered, SLActive®" mini-implant placement + bone augmentation (bone graft "maxgraft® cortico-cancellous granules 0.5-2.0mm" and dental membrane "collprotect®membrane") |
| "Straumann® Bone Level Tapered implants SLA®" mini-implant (hydrophobic surface) | Active comparator | Device: Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)Tooth extraction + "Straumann® Bone Level Tapered , SLA®" mini-implant placement + bone augmentation (bone graft "maxgraft® cortico-cancellous granules 0.5-2.0mm" and dental membrane "collprotect®membrane") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age ≥ 18 years
- Patients with a diagnosed indication for single tooth extraction and scheduled for consented replacement by an implant-based restoration requiring prior bone augmentation
- Only patients displaying periodontally healthy teeth adjacent to the extracted teeth shall be included (probing depth (PD) < 4mm, no bleeding on probing (BOP)
- Patients must be physically and psychologically able to undergo implant surgery and restorative procedures (American Academy of Anesthesiologist class I or II)
Key exclusion criteria (11 listed)
- Presence of any general contra-indication related to implant therapy
- Heavy smokers ( ≥10 cigarettes/day)
- Patients displaying a history of uncontrolled metabolic disorders (e.g. diabetes mellitus)
- Patients with a history of malignancy, radiotherapy, or chemotherapy
- Pregnant or breast feeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface)Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLActive®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane". The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation. | Device | "Straumann® Bone Level Tapered SLActive®" mini-implant (hydrophilic surface) |
| Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLA®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane". The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation. | Device | "Straumann® Bone Level Tapered implants SLA®" mini-implant (hydrophobic surface) |
Primary outcome
Bone-to-Implant Contact (BIC)
Time frame: 3 weeks after implant placement
The cross-sectional implant perimeter percentage in direct contact with newly formed bone over the total cross-sectional implant perimeter. Only the perimeter in contact with augmented bone will be considered for measuring this parameter.
4 secondary outcomes
Percentage of newly formed bone area
Time frame: 3 weeks after implant placement
Graft particle area
Time frame: 3 weeks after implant placement
Assessment of the tissue inflammatory response
Time frame: 3 weeks after implant placement
Assessment of the healing response
Time frame: 3 weeks after implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Perez, Dr principal investigator
University of Geneva, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface) and Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface) in people with Partially Edentulous Maxilla and Partially Edentulous Mandible, run by University Hospital, Geneva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Perez, Dr (+4179 553 50 41, alexandre.perez@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone-to-Implant Contact (BIC) (time frame: 3 weeks after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.