Immediate Implants in the Aesthetic Zone

NCT ID: NCT04343833

Last Updated: 2020-04-14

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2020-04-04

Brief Summary

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The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.

Detailed Description

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20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p\<0.05).

The random distribution is made prior to assignment following the internet prgram https://www.random.org

Conditions

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Immediate Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 20 patients, distributed in two groups with ten patient each (experimental and control) were included in this study. All patients signed a double informed consent, one for implant placement and one for their participation in the study. The study follows the Declaration of Helsinki recommendations. The Ethics Committee of the University of Murcia approved the study protocol with ID: 2076/2018.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double (participant, investigator)

Study Groups

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Control with Standard dental implant

Patients were treated with implants Inhex Ticare Standard (Mozo Grau, Ticare, Valladolid, Spain). The implants presented a surface treated with Reabsorbable Blast Media (RBM), conical macro-design with non-aggressive threads, internal connection, and platform switching. On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º.

Group Type ACTIVE_COMPARATOR

Immediate dental implants

Intervention Type PROCEDURE

At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.

Test with the new implant design

Patients were treated with Implants Inhex Quattro Ticare (Mozo Grau, Ticare, Valladolid, Spain). The implants also presented a surface treated with RBM, conical macro-design with expanded micro threads, internal connection, and platform switching.On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º.

Group Type EXPERIMENTAL

Immediate dental implants

Intervention Type PROCEDURE

At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.

Interventions

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Immediate dental implants

At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.

Intervention Type PROCEDURE

Other Intervention Names

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Fresh extraction sockets

Eligibility Criteria

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Inclusion Criteria

* Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
* Good systemic health status (ASA I or II).
* Oral hygiene index of \< 2 (Löe and Silness).
* A minimum of 2 mm of attached mucosa.
* A minimum of 8 mm of vertical bone.
* A minimum of 7 mm of bucco-lingual bone.

Exclusion Criteria

* Traumatic or complicated incisor extraction.
* Pregnant or women in the lactation period.
* Use of any medication that contraindicates implant treatment.
* A history of alcohol or drug abuse.
* A requirement for guided bone regeneration.
* A requirement for tissue graft augmentation.
* Failure to comply with the study protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Arturo Sánchez-Pérez

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital

Murcia, , Spain

Site Status

Countries

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Spain

References

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Sanchez-Perez A, Nicolas-Silvente AI, Sanchez-Matas C, Molina-Garcia S, Navarro-Cuellar C, Romanos GE. Primary stability and PES/WES evaluation for immediate implants in the aesthetic zone: a pilot clinical double-blind randomized study. Sci Rep. 2021 Oct 8;11(1):20024. doi: 10.1038/s41598-021-99218-8.

Reference Type DERIVED
PMID: 34625591 (View on PubMed)

Other Identifiers

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2076/20018

Identifier Type: -

Identifier Source: org_study_id

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