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

N/ANot Yet RecruitingNCT07246499

University of Valencia25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peri-implant Tissue Healing Assessed by Proteomic Analysis

Interventions

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 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Valencia

Valencia, Valencia, Spain

Outcomes

Primary Outcomes

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.

Time frame: 7 days and 3 months after abutment placement.

Data from ClinicalTrials.gov

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