Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant

NCT ID: NCT06059105

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2024-09-15

Brief Summary

This study is a randomised controlled clinical trial. The patients will be included for the placement of immediate implants with immediate crown placement, to replace maxillary anterior teeth. Any significant differences between the Co-Axis implant and a conventional conical implant will be evaluated.

Detailed Description

Introduction: It is commonly known that the placement of an immediate implant is a technique-sensitive procedure, as the implant should be placed in the palatal aspect for the perfect prosthetic emergence and profile. In order to supply this complexity, there is a novel macroimplant design involving an implant with a 12º angled platform. This angulation of the coronal part of the implant allows perfect emergence of the placement of post-extraction implants, since it is placed at the center of the socket, acquiring the best possible bone. In addition, thanks to the angled neck, prosthetic emergence is ideal, as it is corrected and emerges through the cingulate area, thus securing a perfect emergence profile.

Objectives:

Primary Outcomes: Evaluate the percentage of success and survival of the Inverted Co-Axis 12º Southern Implants versus the Internal Conical (Deep Tapered Conical) South Implants on a 1-2-1 follow-up.

Secondary Outcomes:

1. To evaluate the primary stability of both implant systems through a coefficient stability if implants using the Penguin RFA;

2. To evaluate the horizontal and vertical marginal bone loss via a CBCT, 1 year after implant placement;

3. To evaluate the soft tissues via the Pink Esthetic Score (PES) 1 year post-op.

Materials and Methods: Patients were randomly assigned in 2 groups of 15 patients, conical or inverta co-axis implants. Immediate implants in the aesthetic zone of the superior maxilar were placed with an immediate provisional crown restoration. In the same surgery, a connective tissue graft was performed. Only type I sockets according to the Elian Classification were eligible for this study.

Conditions

Dental Implant Failed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Group

Inverted Co-Axis 12º Southern Implants (15 patients): The implant is placed in the center of the socket due to that has an angled neck of 12º, which allows the implant to be placed in the center of the alveolus, optimizing the alveolar bone and improving the prosthetic emergence. This is due to the access of the screw being located palatally, simplifying the restoration of the crown, avoiding cemented crowns, lowering the laboratory cost and of prosthetic accessories.

Group Type: EXPERIMENTAL

Immediate Implant Surgery

Intervention Type: DEVICE

Inverted Co-Axis 12º Southern Implants

Control Group

Internal Conical (Deep Tapered Conical) South Implants (15 patients): conventional conical implant with internal connection. The implant is placed palatally in order to have a good emergence profile.

Group Type: ACTIVE_COMPARATOR

Immediate Implant Surgery

Intervention Type: DEVICE

Internal Conical (Deep Tapered Conical) South Implants

Interventions

Immediate Implant Surgery

Inverted Co-Axis 12º Southern Implants

Intervention Type: DEVICE

Immediate Implant Surgery

Internal Conical (Deep Tapered Conical) South Implants

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who presented with a good well-being status and no contraindication for undergoing an oral surgical procedure
• Patients aged 18 and over
• Adequate oral hygiene, with patient's presenting a plaque index lower than 15% using the Index Scale publish by Löe et al.
• Patients who demonstrated motivation and compiled by attending the allocated follow-up appointments
• One single tooth indicated to be extracted due to having a poor prognosis in the maxilla (central or lateral incisors, canines or premolars)
• Absence of vestibular dehiscence in the bone table and presence of soft tissue without recession (Alveolus type I according to the classification of Elian et al. which could be determined on the day of surgery
• Sufficient bone to allow implant placement with primary stability
• To avoid image blurring or artefacts during CBCT, patients were included if they did not have a bridge or amalgam restoration close to the implant placement.

Exclusion Criteria

• If the patient presented with an acute infection in the tooth where the implant is to be placed
• Absence of posterior sector in which it would cause an occlusal overload
• Alveolus with enough space to place an implant with a diameter of 4.5mm (since implants with a 3.5 coronal diameter have a widening in the middle third of the implant of 4.5mm)
• Patients with an unstable periodontal status
• Patients who smoked more than 10 cigarettes a day
• Patients who had medical histories which contraindicate implant surgery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

JAVIER GAMON

Clinical Project Manager Dentistry faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Andrea Galve

Role: CONTACT

andreagalve@UIC.es

+34659051487

Javier Gamon

Role: CONTACT

jgamon@uic.es

+34627321249

Facility Contacts

Andrea Galve

Role: primary

andreagalve@UIC.es

+34659051487

Javier Gamon

Role: backup

jgamon@uic.es

+34627321249

Other Identifiers

CIR-ELC-2021-09

Identifier Type: -

Identifier Source: org_study_id