Teeth AbsentNCT05118815
Peri-implant Tissues on the Galimplant Anti-rotational Slim Abutment.
A study testing Slim abutment and Standard abutment in people with Teeth Absent and Tooth-loss, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Teeth Absent, Tooth-loss, Tooth Extraction
- What is being tested?
- Slim abutment and Standard abutment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2022to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15785
About this study
Official title: 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.
Read the 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.
- Conditions
- Teeth Absent, Tooth-loss, Tooth Extraction, Dental Implant
- Being tested
- Slim abutment, Standard abutment
- Keywords
- oral rehabilitation, dental implants, marginal bone loss, periimplant tissues, abutments
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slim abutmentOther
Use a narrower abutment to see if they present a better biological seal.
Standard abutmentOther
Use a standard abutment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Slim abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 36 months
Abutment stability
Basal and 3 months postimplantation measured by Implant Stability Quotient (ISQ).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start21 Feb 2022
- Primary completion2 May 2023
- Study completion29 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth AbsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca, University of Valencia, Universidad de Murcia, Health Research Institute of Santiago
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
- Investigators
- Mario Pérez-Sayáns, PhD, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118815
- Sponsor's protocol ID
- MC/TP/2021
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Behavior of Peri-implant Tissues on the New Anti-rotational Slim Abutment Galimplant. Single-blind Randomized Multicenter Clinical Trial.
- ClinicalTrials.gov ID
- NCT05118815
- Acronym / sponsor ID
- MC/TP/2021
- Conditions
- Teeth Absent, Tooth-loss, Tooth Extraction, Dental Implant
- Keywords
- oral rehabilitation, dental implants, marginal bone loss, periimplant tissues, abutments
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- University of Salamanca, University of Valencia, Universidad de Murcia, Health Research Institute of Santiago
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 29 Jul 2025 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Conventional straight esthetic abutment | Active comparator | Other: Standard abutmentAfter 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. |
| Slim (New Slim) transepithelial abutment | Experimental | Other: Slim abutmentAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slim abutmentUse a narrower abutment to see if they present a better biological seal. | Other | Slim (New Slim) transepithelial abutment |
| Standard abutmentUse a standard abutment | Other | Conventional straight esthetic abutment |
Primary outcome
Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments
Time frame: 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.
6 secondary outcomes
Inflammatory response rate
Time frame: 3 months
Epithelial thickness and orientation of the collagen fibers
Time frame: 3 months
Vascular density of the peri-implant mucosa
Time frame: 3 months
Remnant soft tissue and/or microorganisms
Time frame: 3 months
Mesial and distal marginal bone loss
Time frame: 36 months
Abutment stability
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes. We will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Pérez-Sayáns, PhD principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slim abutment and Standard abutment in people with Teeth Absent and Tooth-loss, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant mucosa located around conventional esthetic abutments and the new Slim Galimplant abutments (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.