Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants (NCT06460103) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants
70 participantsStarted 2024-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.