Back to resultsPeri-implant Tissues on the Galimplant Anti-rotational Slim Abutment.
Primary Purpose
Teeth Absent, Tooth-loss, Tooth Extraction
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Slim abutment
Standard abutment
Sponsored by
About this trial
This is an interventional other trial for Teeth Absent focused on measuring oral rehabilitation, dental implants, marginal bone loss, periimplant tissues, abutments
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.
Sites / Locations
- Universidad de Santiago de Compostela
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional straight esthetic abutment
Slim (New Slim) transepithelial abutment
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
Abutment stability
Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Full Information
NCT ID
NCT05118815
First Posted
October 16, 2021
Last Updated
May 11, 2023
Sponsor
University of Santiago de Compostela
Collaborators
University of Salamanca, University of Valencia, Universidad de Murcia, Health Research Institute of Santiago
1. Study Identification
Unique Protocol Identification Number
NCT05118815
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
July 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
Collaborators
University of Salamanca, University of Valencia, Universidad de Murcia, Health Research Institute of Santiago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth Absent, Tooth-loss, Tooth Extraction, Dental Implant
Keywords
oral rehabilitation, dental implants, marginal bone loss, periimplant tissues, abutments
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional straight esthetic abutment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Slim (New Slim) transepithelial abutment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Slim abutment
Intervention Description
Use a narrower abutment to see if they present a better biological seal.
Intervention Type
Other
Intervention Name(s)
Standard abutment
Intervention Description
Use a standard abutment
Primary Outcome Measure Information:
Title
Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Inflammatory response rate
Description
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.
Time Frame
3 months
Title
Epithelial thickness and orientation of the collagen fibers
Description
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.
Time Frame
3 months
Title
Vascular density of the peri-implant mucosa
Description
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.
Time Frame
3 months
Title
Remnant soft tissue and/or microorganisms
Description
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).
Time Frame
3 months
Title
Mesial and distal marginal bone loss
Description
To clinically compare mesial and distal marginal bone loss using standardized digital periapical radiographs with parallel technique. Control at 12, 24 and 36 months.
Time Frame
36 months
Title
Abutment stability
Description
Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Pérez-Sayáns, PhD
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Santiago de Compostela
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15785
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Peri-implant Tissues on the Galimplant Anti-rotational Slim Abutment.
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