Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.
NCT ID: NCT07246499
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2025-11-30
2026-06-30
Brief Summary
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The main question it seeks to answer is:
\- In dental abutments, is anodised surface more effective than machined surface in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two dental abutments applied as part of the standard surgical procedure. Subsequently, participants will undergo clinical and proteomic follow-up assessments to evaluate the progress and extent of peri-implant tissue healing over a three-months period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pink anodized titanium implant abutment.
Participants will receive a pink anodized implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.
Pink anodized implant abutment.
Participants will receive a pink anodized titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis.
Grey machined titanium implant abutment.
Participants will receive a grey machined implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.
Grey machined implant abutment.
Participants will receive a grey machined titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis.
Interventions
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Grey machined implant abutment.
Participants will receive a grey machined titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis.
Pink anodized implant abutment.
Participants will receive a pink anodized titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A minimum of 4 implants, either single or bridges, must always be used in order to place 2 machined abutments and 2 anodised abutments.
* Sufficient bone dimensions for a minimum implant diameter of 3.5-4 mm and length of 6-8 mm, without prior bone regeneration.
* Patients who require indirect breast lift simultaneously with implant placement may be included in the study.
* Minimum keratinised mucosa dimension of 1.5-2.0 mm in all directions.
* Previous healthy bone condition for 3 months without infection.
* Periodontal health with no history of periodontitis (Silness and Löe plaque index, bleeding on probing (BOP) \< 3 mm).
Exclusion Criteria
* Implant failures.
* Contamination of the sample during transfer from the abutment to the test tube.
18 Years
ALL
No
Sponsors
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University of Santiago de Compostela
OTHER
University of Valencia
OTHER
Responsible Party
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Juan Carlos Bernabeu Mira
Professor, PhD.
Locations
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University of Valencia
Valencia, Valencia, Spain
Countries
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Facility Contacts
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Other Identifiers
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1. UV-INV_ETICA-3792382
Identifier Type: -
Identifier Source: org_study_id
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