X-space Implants in Post-extraction Sites. (NCT04492111) | Clinical Trial Compass
CompletedNot Applicable
X-space Implants in Post-extraction Sites.
Italy30 participantsStarted 2020-09-02
Plain-language summary
Several recent systematic reviews have highlighted how the macrodesign of dental implants can influence stress distribution and biomechanical and biological behavior in implants immediately inserted in post-extraction sites. Finite element analyzes have confirmed the benefit of the inclination of the implant threads in reducing implant displacement in post-extraction sites, increasing primary stability, and decreasing stress in contact with the trabecular bone.
Other comparative studies have shown that the design of the threads of the implant does not affect the distribution of stress in the surrounding bone.
In view of the need to evaluate the influence of implant macrodesign in the case of implants inserted in post-extraction alveoli, this study will examine the clinical results of two different types of implants with different macrodesigns, with the aim of providing scientific evidence in this regard.
The present study will investigate through a randomized controlled trial the effect of thread macrodesign of X-space implants on primary stability and osseointegration when inserted in post-extraction sites, as compared to cylindric 2P implants.
Who can participate
Age range
20 Years – 80 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:
* Absence of systemic or local diseases that could compromise implant or prosthetic therapy
* Good periodontal health, assessed by periodontal indices
* Presence of premolar / canine / incisor teeth and with extraction indications and with the presence of two adjacent natural teeth.
* Absence of probing greater than 4mm in the vestibular wall of the crestal bone
Exclusion Criteria:
* CT scan performed in the last 5 years
* Active periodontal diseases
* Heavy smokers (more than 20 cigarettes per day)
* Consumers of high alcohol levels
* Therapy with corticosteroids, immunosuppressive therapies, chemotherapy, radiotherapy, pregnancy
* Lack of collaboration for continuous post-intervention re-evaluations
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.