Peri-implant Tissues on the Galimplant Anti-rotational Slim Abutment.

Characterization and Behavior of Peri-implant Tissues on the New Anti-rotational Slim Abutment Galimplant. Single-blind Randomized Multicenter Clinical Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Implant; Tooth Extraction; Tooth-loss; Teeth Absent
• Intervention / Treatment: Other: Standard abutment; Other: Slim abutment

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cintia M. Chamorro Petronacci; Phone Number: 0034651011815; Email: cintia.chamorro.petronacci@gmail.com

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15785
      • Universidad de Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional straight esthetic abutment; After implant surgery, 30 patients will have a 3 mm high conventional straight esthetic abutment placed. The implant placement will follow the manufacturer's instructions and the operator's expertise to achieve stability with an insertion torque of at least 40 N, recording the final torque with a calibrated torque wrench. The implant will be placed whenever bone and gingival availability allows it, juxta-osseous to avoid collateral damage in the peri-implant perimetral soft tissue excision (donut). The abutment will be placed at 30 N as indicated by the manufacturer. After removal of the donut, a new abutment will be placed and left in place up to 3 months to allow healing and complete osseointegration. Patients will receive prosthodontic loading following standard metal-ceramic rehabilitation protocols and the manufacturer's recommendation. The prosthesis will be screw-retained, on the abutment placed after excision of the donut, screwed at 25 N.	Other: Standard abutment; Use a standard abutment
Experimental: Slim (New Slim) transepithelial abutment; After surgery, 30 patients will have a 3 mm high transepithelial New Slim abutment placed. The implant placement will follow the manufacturer's instructions and the operator's expertise to achieve stability with an insertion torque of at least 40 N, recording the final torque with a calibrated torque wrench. The implant will be placed whenever bone and gingival availability allows it, juxta-osseous to avoid collateral damage in the peri-implant perimetral soft tissue excision (donut). The abutment will be placed at 30 N as indicated by the manufacturer. After removal of the donut, a new abutment will be placed and left in place up to 3 months to allow healing and complete osseointegration. Patients will receive prosthodontic loading following standard metal-ceramic rehabilitation protocols and the manufacturer's recommendation. The prosthesis will be screw-retained, on the abutment placed after excision of the donut, screwed at 25 N	Other: Slim abutment; Use a narrower abutment to see if they present a better biological seal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory response rate	To compare the inflammatory response of the peri-implant mucosa located around conventional esthetic abutments and the new Slim abutments; by immunohistochemical quantification of T cells, B cells, macrophages, and PMNs.	3 months
Epithelial thickness and orientation of the collagen fibers	To compare the epithelial thickness and orientation of the collagen fibers of the peri-implant mucosa located around conventional and Slim abutments through a sample of peri-implant mucosa. One of the sections will be stained with HE, and we will use Image J image analysis software version 1.46 (U.S National Insitutes of Health, Bethesda, USA), calculating the mean of 25 thickness measurements for each of the samples. The other section will be stained with Masson-Goldner trichrome. With this staining, the light intensity will be increased for viewing the samples with a polarised light microscope. Collagen fibres aligned transverse to the direction of light propagation (parallel to the plane of section), will appear bright due to a change in the refraction of the existing light, whereas collagen fibres aligned along the axis of light propagation (perpendicular to the plane of section), will appear dark because no refraction occurs. Each sample will be observed at 5X, 10X, and 20W.	3 months
Vascular density of the peri-implant mucosa	To analyze and compare the vascular density of the peri-implant mucosa located around conventional esthetic abutments and the new Slim abutments through a sample of peri-implant mucosa by means of a section around the transepithelial abutment, with a circular biopsy scalpel of 6 mm diameter designed ad hoc, obtaining a sample of 1.5-2 mm.	3 months
Remnant soft tissue and/or microorganisms	To determine and compare the presence of remnant soft tissue and/or microorganisms on the surface of conventional esthetic abutments and the new Slim abutments we will use the SEM (Oxford Instruments INCA 300 EDX System, Abringdon, Oxfordshire, UK), and images will be captured using Semafore software (Semafore, JEOL, Tokyo, Japan).	3 months
Mesial and distal marginal bone loss	To clinically compare mesial and distal marginal bone loss using standardized digital periapical radiographs with parallel technique. Control at 12, 24 and 36 months.	36 months
Abutment stability	Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).	3 months

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Universidad de Murcia; University of Valencia; University of Salamanca; Health Research Institute of Santiago
• Investigators: Principal Investigator: Mario Pérez-Sayáns, PhD, University of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): May 2, 2023
• Study Completion (Anticipated): July 29, 2025

Study Registration Dates

• First Submitted: October 16, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: dental implants; marginal bone loss; periimplant tissues; oral rehabilitation; abutments
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: MC/TP/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group
• IPD Sharing Time Frame: Under request
• IPD Sharing Access Criteria: Under request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No