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

NCT06059105 | Unknown

• 1 other identifier: CIR-ELC-2021-09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failed

Keywords

co-axis implant; dental implant; implant angulation; success rate; marginal bone loss

Outcome Measures

Primary Outcomes (2)

• Success Rate

  ICOI Pisa Implant quality of Health Criteria

  1 year

• Survival Rate

  "the implant is still in mouth",

  1 year

Secondary Outcomes (3)

• Horizontal and Vertical bone Changes

  1 year

• Implant primary stability

  Right after the implant placement

• Status of the soft tissues

  At 1 year

Study Arms (2)

Test Group

EXPERIMENTAL

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.

Device: Immediate Implant Surgery

Control Group

ACTIVE COMPARATOR

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.

Device: Immediate Implant Surgery

Interventions

Immediate Implant Surgery DEVICE

Inverted Co-Axis 12º Southern Implants

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Central Study Contacts

Andrea Galve

CONTACT

+34659051487; andreagalve@UIC.es

Javier Gamon

CONTACT

+34627321249; jgamon@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Project Manager Dentistry faculty

Model Details: The patients will be randomized into two groups. The test group (n=15) will be treated with the Inverta Co-Axis 12º implant (Southern Implants). In the control group (n=15) the Internal Conical implants (Southern implants) will be used. The difference between both implants lies in the fact that the Inverta Co-Axis 12º implant presents two different variants to the classic implant with parallel walls (Internal Conical)

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 28, 2023
• Study Start: March 15, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ES (1)