Effect of Implant Surface Material and Topography on Bone Regeneration. (NCT05890469) | Clinical Trial Compass
CompletedNot Applicable
Effect of Implant Surface Material and Topography on Bone Regeneration.
United Kingdom12 participantsStarted 2024-05-01
Plain-language summary
Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing hydrophilic titanium and zirconia implants. In addition, there is no data available on the signalling pathways and the expression of healing biomarkers involved in the early stages of osseointegration around zirconia surface implants placed with guided bone regeneration (GBR).
This study aims 1) to describe and compare the early wound healing molecular pathways, and the 2) vascularization patterns of mucosal tissues after the placement of hydrophilic titanium or zirconia implants with simultaneous guided bone regeneration (GBR).
In this study, the investigators will assess the expression of inflammatory, angiogenesis and osseous biomarkers of PICF at 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants with simultaneous GBR and of saliva at day 1, 3, 7, 15 and 30.
Who can participate
Age range
25 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:
* Males and females, ≥ 25 years old
* Good/controlled medical and psychological health
* Good oral hygiene (full mouth plaque scores \[FMPS\< 30%\])
* Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
* At least one neighbouring natural tooth present
* A functional occlusion with a minimum of four occlusal units (i.e., pairs of occluding posterior teeth)
* At least 3 months of post-extraction socket healing had occurred in the edentulous site and no ridge preservation was performed
* After implant placement, presence of buccal bone dehiscence/fenestration or thin buccal bone plate (\<2mm) requiring guided bone regeneration (GBR) (including contour augmentation) \[to be confirmed after implant placement\]
* Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered
Exclusion Criteria:
* Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II)
* Self-reported HIV or viral hepatitis
* Self-reported alcoholism or chronic drug abuse
* Smokers (including current smokers or former smokers who had quit for \< 3 months); patients reporting use of vape/ e-cigarettes will also be excluded
* Self-reported pregnancy or lactation (this…
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
Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva
Timeframe: 1,3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants.