Slim abutment: Use a narrower abutment to see if they present a better biological seal.
Standard abutment: Use a standard abutment
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 \<40N, or with abutments that cannot receive torque at 30N are excluded.
Primary outcome measure(s)
Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments — 3 months To histologically and immunohistochemically compare the peri-implant mucosa through a sample of peri-implant mucosa by means of a section around the transepithelial abutment, obtaining a 1.5-2 mm sample that will be fixed in 10% formaldehyde and transferred to the University of Murcia for histological and immunohistochemical study. The portion of peri-implant mucosa will be deparaffinised and two sections of 5 µm each will be obtained. One, stained with HE and analysed with software Image J version 1.46, calculating the average of 25 thickness measurements for each of the samples.The other 5 µm section will be stained with Masson-Goldner trichrome as a birefringent stain to facilitate the accuracy of the study.
Trial sites (1)
Facility
City
Region
Status
Universidad de Santiago de Compostela
Santiago de Compostela
A Coruña
More University of Santiago de Compostela trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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