Clinical trial NCT05118815: Peri-implant Tissues on the Galimplant Anti-rotational Slim Abutment.
Official title: Characterization and Behavior of Peri-implant Tissues on the New Anti-rotational Slim Abutment Galimplant. Single-blind Randomized Multicenter Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Teeth Absent
Tooth-loss
Tooth Extraction
Dental Implant
Keywords: oral rehabilitation
dental implants
marginal bone loss
periimplant tissues
abutments
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: University of Salamanca
name: University of Valencia
name: Universidad de Murcia
name: Health Research Institute of Santiago
First posted: 2021-11-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 60 dental implants Hexagonal Internal Connection Implants (Model IPX), Galimplant® will be used in this study, for the replacement of bilateral maxillary posterior missing teeth in 30 patients (split-mouth study). For the designation of the type of transepithelial abutment to be placed in each hemimaxillary, we will use an online randomization service (www.randomization.com). After surgery, 30 patients will have a conventional straight esthetic abutment 3 mm in height (control group), and the other 30 will have a Slim (New Slim) transepithelial abutment of the same height (test group); in no case will we place the transepithelial closure abutment to achieve contact of the peri-implant mucosa with the surface of the transepithelial abutments. The implant will be placed whenever bone and gingival availability allows it juxta-osseous to avoid collateral damage in the exeresis of the peri-implant perimetral soft tissue (hereinafter donut)
Primary purpose: OTHER

Brief 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.

Detailed description: Throughout implantological history there have been many proposals and modifications in terms of anchorage system, shape, materials, etc. In this project we intend to compare a classic anti-rotational straight esthetic multi-position attachment with the new anti-rotational straight esthetic slim multi-position abutment.

This will hypothetically allow to increase the contact surface of the peri-implant connective tissue, increase the adhesion and sealing power, improve the biological width and consequently minimize the risk of peri-implant diseases such as mucositis and peri-implantitis.

In this regard, we must analyze the healing process of the peri-implant soft tissue after surgery, which will result in a stable peri-implant mucosa. After surgery, soft tissue healing around the transmucosal portion of an implant begins with the formation of a blood clot and the induction of an inflammatory process aimed at tissue formation and remodeling. If that soft tissue formation and remodeling is adequate, the healing process will result in an effective attachment mucosa around the transmucosal portion of the implant.

To obtain this adequate peri-implant mucosa, it is very important that a proper healing process takes place. This process includes the recruitment of inflammatory cells and a process of angiogenesis; and if both processes are correctly developed, all the phases of mucosal healing (hemostasis, inflammation, proliferation, and remodeling of the collagen matrix) will occur successfully.

Eligibility criteria: 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 outcomes:
measure: Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments
timeFrame: 3 months
Secondary outcomes:
measure: Inflammatory response rate
timeFrame: 3 months
measure: Epithelial thickness and orientation of the collagen fibers
timeFrame: 3 months
measure: Vascular density of the peri-implant mucosa
timeFrame: 3 months
measure: Remnant soft tissue and/or microorganisms
timeFrame: 3 months
measure: Mesial and distal marginal bone loss
timeFrame: 36 months
measure: Abutment stability
timeFrame: 3 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Universidad de Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Mario Pérez-Sayáns, PhD
role: PRINCIPAL_INVESTIGATOR
References: