Peri-implant Tissues on the Galimplant Anti-rotational Slim Abutment. (NCT05118815) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Peri-implant Tissues on the Galimplant Anti-rotational Slim Abutment.
Spain5 participantsStarted 2022-02-21
Plain-language summary
A dental implant is an alloplastic material surgically inserted in a residual bone ridge, mainly with a prosthetic foundation. Nowadays the most widely used implants and with a higher degree of scientific evidence are the titanium root-form endosseous implants. In addition to the root component, the prosthodontic systems that allow the crown to be connected to the implant are very important. The aim of this project is to compare a classic anti-rotational straight esthetic multi-position attachment with the new anti-rotational straight esthetic slim multi-position abutment, both placed at the time of implant surgery. A multicenter randomized single-blind (for the patient) split-mouth randomized clinical trial will be performed to compare the composition, distribution and structure of the peri-implant tissues around the classic straight (control) and Slim (test) intermediate prosthetic abutments of the manufacturer Galimplant (Sarria; Lugo, Spain). The objective is to study which abutment design obtains a better biological seal from the clinical and histomorphometric point of view. For this purpose, 60 dental implants will be placed for the replacement of bilateral posterior absences in 30 patients attending the Master of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela, Spain.
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:
* Patients who meet all the inclusion criteria and none of the exclusion criteria will be informed verbally and in writing about the study and will sign the informed consent form provided for their participation.
* Systemic conditions favorable for the performance of oral surgical procedures (ASA I/II).
* Not to be completely edentulous
* Bilateral absence of at least two teeth (one per hemimaxillary) in the posterior area (from the first premolar to the second molar) with or without free distal ends.
* That do not require regenerative techniques
* That allow the placement of Galimplant implants of 4.5 or 5 mm in diameter in edentulous areas with mature bone of at least 3 months healing time
* With a prosthetic space of at least 8 mm.
* In case of odd absences, a slim abutment will be placed, being the group to be tested always in the majority.
Exclusion Criteria:
* Presence of any disease, condition or medication that may compromise the healing and/or osseointegration of dental implants (uncontrolled diabetes mellitus, immunosuppression, administration of bone modifying agents (BMA). Presence of any severe mental disorder, and patients who have received head and neck radiotherapy during the previous 18 months.
* Patients who do not have sufficient peri-implant keratinized gingiva to allow at least 1 mm of residual gingiva after excision of the tissue under study.
* Esthetic edentulous areas of 13-23, Implants with primary stability with ISQ \< 50 or \<…
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
Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments