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Completed

NCT Number: NCT07246499

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

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.

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Key information

Conditions

Peri-implant Tissue Healing Assessed by Proteomic Analysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pink anodized implant abutment.

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.

Other names: Pink anodized dental abutment, Anodized titanium abutment

Grey machined implant abutment.

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.

Other names: Grey machined dental abutment, Machined titanium abutment

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • University of Santiago de Compostela

Registry information

Official study title

Characteristics of Transmucosal Abutments for Dental Implants.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.