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

May 13, 2026 updated by: Juan Carlos Bernabeu Mira, University of Valencia

Characteristics of Transmucosal Abutments for Dental Implants.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pink anodized titanium implant abutment.
Participants will receive a pink anodized implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.
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.
Other Names:
  • Pink anodized dental abutment
  • Anodized titanium abutment
Active Comparator: Grey machined titanium implant abutment.
Participants will receive a grey machined implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.
Device: 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.
Other Names:
  • Grey machined dental abutment
  • Machined titanium abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomic analysis of peri-implant tissue healing.
Time Frame: 7 days and 3 months after abutment placement.
Proteomic profiling of peri-implant tissues will be performed to characterise protein expression patterns associated with tissue healing, enabling the identification of molecular markers of tissue regeneration.
7 days and 3 months after abutment placement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

University of Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1. UV-INV_ETICA-3792382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing of individual participant data is under consideration. Should data be shared in the future, all institutional regulations will be followed to protect participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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