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

NCT07246499 | Not Yet Recruiting

• 1 other identifier: 1. UV-INV_ETICA-3792382
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Tissue Healing Assessed by Proteomic Analysis

Keywords

peri-implant healing; proteomics; tissue regeneration; Evaluation of proteomic outcomes in peri-implant tissue healing.; Pink anodized implant abutment; Grey machined implant abutment

Outcome Measures

Primary Outcomes (1)

• Proteomic analysis of peri-implant tissue healing.

  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.

Study Arms (2)

Pink anodized titanium implant abutment.

EXPERIMENTAL

Participants will receive a pink anodized implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.

Device: Pink anodized implant abutment.

Grey machined titanium implant abutment.

ACTIVE COMPARATOR

Participants will receive a grey machined implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis.

Device: Grey machined implant abutment.

Interventions

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.

Also known as: Pink anodized dental abutment, Anodized titanium abutment

Pink anodized titanium implant 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.

Also known as: Grey machined dental abutment, Machined titanium abutment

Grey machined titanium implant abutment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead
• University of Santiago de Compostela: collaborator

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-10

Locations

ES (1)