Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.

NCT ID: NCT07246499

Last Updated: 2025-11-24

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-06-30

Brief Summary

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The main objective of the study is to perform proteomic adsorption analysis on machined (grey) and anodised (pink) surfaces and compared them. The aim is to evaluate the regenerative potential involving improvement in the healing of peri-implant soft tissues in patients with dental implants. This surgery is indicated in healthy patients when they lost their teeth.

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.

Detailed Description

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Conditions

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Peri-implant Tissue Healing Assessed by Proteomic Analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type EXPERIMENTAL

Pink anodized implant abutment.

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Grey machined implant abutment.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Pink anodized dental abutment Anodized titanium abutment Grey machined dental abutment Machined titanium abutment

Eligibility Criteria

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Inclusion Criteria

* Number of missing teeth and, therefore, number of implants required.
* 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

* Patients unable to complete follow- up.
* Implant failures.
* Contamination of the sample during transfer from the abutment to the test tube.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Santiago de Compostela

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Juan Carlos Bernabeu Mira

Professor, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Facility Contacts

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Official Title: Professor of Oral Surgery, PhD.

Role: primary

+34 697348312

Official Title: Full Professor of Oral Surgery, PhD.

Role: backup

+34 697348312

Other Identifiers

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1. UV-INV_ETICA-3792382

Identifier Type: -

Identifier Source: org_study_id

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