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

NCT05118815 | Active Not Recruiting

• 1 other identifier: MC/TP/2021
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Teeth Absent; Tooth-loss; Tooth Extraction; Dental Implant

Keywords

oral rehabilitation; dental implants; marginal bone loss; periimplant tissues; abutments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Inflammatory response rate

  3 months

• Epithelial thickness and orientation of the collagen fibers

  3 months

• Vascular density of the peri-implant mucosa

  3 months

• Remnant soft tissue and/or microorganisms

  3 months

• Mesial and distal marginal bone loss

  36 months

Study Arms (2)

Conventional straight esthetic abutment

ACTIVE COMPARATOR

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

Slim (New Slim) transepithelial abutment

EXPERIMENTAL

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

Interventions

Slim abutment OTHER

Use a narrower abutment to see if they present a better biological seal.

Slim (New Slim) transepithelial abutment

Standard abutment OTHER

Use a standard abutment

Conventional straight esthetic abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• University of Salamanca: collaborator
• University of Valencia: collaborator
• Universidad de Murcia: collaborator
• Health Research Institute of Santiago: collaborator

Study Sites (1)

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15785, Spain

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mario Pérez-Sayáns, PhD

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: November 12, 2021
• Study Start: February 21, 2022
• Primary Completion: May 2, 2023
• Study Completion: July 29, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Under request
• Access Criteria: Under request

Locations

ES (1)