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

University of Valencia

Status: Not yet enrolling

Conditions: Peri-implant Tissue Healing Assessed by Proteomic Analysis

Treatments: Device: Pink anodized implant abutment.; Device: Grey machined implant abutment.

Study type: Interventional

Funder types: Other

Identifiers

NCT07246499

1. UV-INV_ETICA-3792382

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Pink anodized titanium implant abutment.

Experimental group

Description:

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

Treatment:

Device: Pink anodized implant abutment.

Grey machined titanium implant abutment.

Active Comparator group

Description:

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

Treatment:

Device: Grey machined implant abutment.