Influence of Neck Design on Peri-implant Hard and Soft Tissues

Universitat Internacional de Catalunya

Status: Completed

Conditions: Soft Tissue Bleeding; Bone Resorption

Treatments: Device: Immediate implant surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05944419

CIR-ECL-2016-05

Details and patient eligibility

About

The goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question[s] it aims to answer are:

• do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at one year?
• do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at three years?

Participants that present an unrepairable tooth on the anterior upper maxilla will be asked to take a CBCT scan in order to verify the presence of the buccal bone. Once this is verified the patients will enter in the study and the day of the surgery they will be assigned to either control or test group.

• Control group: C1 round-neck implant
• Test groups: V3 triangular-implant neck

Researchers will compare test and control groups to see if they have the same effects on hard and soft tissues at 4 months, 1 year and 3 years.

Full description

Immediate implant placement is considered to be a technique-sensitive protocol with a variety of potential risks. The interface area between the neck of the implant and the abutment is critical; it can affect the treatment outcome, particularly mar-ginal bone loss (MBL) and soft tissue behavior. Traditionally, the implant neck is circu-lar in shape; however, a new triangular neck design has recently been introduced on the market, though advanced indications of this innovative design are still lacking.

The objective of this randomized clinical trial was to compare the clinical and radiographic outcomes obtained after immediate placement of implants and temporization of two different neck geometries: a traditional round neck (RN) and an innovative neck with a triangular shape (TN).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy non-smokers or light smokers (< 10 cigarettes/day)
• adults (> 18 years of age),
• need for single tooth extraction of a maxillary incisor, canine or premolar
• adequate oral hygiene
• ability to follow instructions and attend the required appointments
• presence of a length of at least 3 mm of buccal bone measuring ≥ 0.5 mm in thickness, apical to the extraction socket
• stable and intact socket walls

Exclusion criteria

• patients with acute infections in the area of interest
• individuals with large occlusal discrepancies and/or occlusal overload para-functions
• smokers of more than 10 cigarettes/day
• patients with any medical condition or medication contraindicating dental implant treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

V3 Implant MIS Iberica

Active Comparator group

Description:

Implant with triangular neck macro design

Treatment:

Device: Immediate implant surgery

C1 Implant MIS Iberica

Active Comparator group

Description:

Implant with circular neck macro design

Treatment:

Device: Immediate implant surgery