Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces. (NCT05558800) | Clinical Trial Compass
CompletedNot Applicable
Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.
Lebanon11 participantsStarted 2018-01-01
Plain-language summary
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.
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:
* • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.
* Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
* Healed bone crest (≥ 3 months elapsed after extraction or tooth loss).
* Age \> 18 years.
* Ability to examine and fully understand the study protocol.
Exclusion Criteria:
* • Myocardial infarction within the past 6 months.
* Poorly controlled diabetes (HBA1c \> 7.5%).
* Coagulation disorders.
* Radiotherapy to the head/neck area within the past two years.
* Present or past treatment with intravenous bisphosphonates.
* Immunocompromised patients.
* Psychological or psychiatric problems.
* Alcohol or drug abuse.
* Poor oral hygiene and motivation (full mouth plaque score \> 30% and/or full mouth bleeding score \> 20%).
* Uncontrolled periodontal disease.
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.
What they're measuring
1
Bone to implant contact
Timeframe: 4 weeks healing period after implant placement
2
Bone to implant contact
Timeframe: 6 weeks healing period after implant placement