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

NCT ID: NCT05944419

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-15

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Bone Resorption Soft Tissue Bleeding

Keywords

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dental implants implant neck design immediate implants immediate provisionalization buccal bone thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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V3 Implant MIS Iberica

Implant with triangular neck macro design

Group Type ACTIVE_COMPARATOR

Immediate implant surgery

Intervention Type DEVICE

Placement of immediate implant and immediate provisionalization after tooth extraction

C1 Implant MIS Iberica

Implant with circular neck macro design

Group Type ACTIVE_COMPARATOR

Immediate implant surgery

Intervention Type DEVICE

Placement of immediate implant and immediate provisionalization after tooth extraction

Interventions

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Immediate implant surgery

Placement of immediate implant and immediate provisionalization after tooth extraction

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Jordi caballé

Dr, MSc, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CRISTINA PORTA FERRER

Role: PRINCIPAL_INVESTIGATOR

Universitat Internacional de Catalunya

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CIR-ECL-2016-05

Identifier Type: -

Identifier Source: org_study_id