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Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site

NCT ID: NCT06157047

Last Updated: 2023-12-05

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-07-15

Brief Summary

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The purpose of the study is to evaluate the use of a magnetodynamic instrument (Magnetic Mallet®, Metaergonomica, Turbigo, Italy) to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.

Detailed Description

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From October 2019 to May 2022, a sample of 15 patients, 11 men and 4 women, age between 39 and 78 years, was analyzed. A total of 18 conical-shaped implants with a diameter of 3.80 mm and a length between 10 and 11.5 mm were inserted in the maxillary region in the area between the lateral incisor and the first upper molar. The patients were treated by two different surgeons.

Conditions

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Edentulous Alveolar Ridge

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients included

Patients' recruitment was guided by their actual need to solve edentulism through the use of implant therapy. The diagnosis was made clinically and radiographically.

Group Type EXPERIMENTAL

Crestal Bone Expansion obtained with the Magnetic Mallet®

Intervention Type PROCEDURE

A magnetodynamic instrument (Magnetic Mallet®, Metaergonomica, Turbigo, Italy) has been used to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.

Interventions

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Crestal Bone Expansion obtained with the Magnetic Mallet®

A magnetodynamic instrument (Magnetic Mallet®, Metaergonomica, Turbigo, Italy) has been used to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with maxillary mono-edentulism between the lateral incisor and the first upper molar with a bone crest measuring between 4-6 mm;
* Insertion of conical implants with dimensions 3.80 x \> 10 mm;
* Correct occlusal relationships between upper and lower jaw;
* Patients willing to cooperate and follow the instructions given by the clinicians.

Exclusion Criteria

* Smokers \> 15 cigarettes per day;
* Patients with systemic diseases;
* Irradiation to the head/neck region within 12 months prior to surgery;
* Pregnancy or breastfeeding;
* Poor oral hygiene and lack of motivation to return for checkups;
* Edentulous area for less than 1 year;
* Edentulousness of the lower jaw.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paolo Pesce

OTHER

Sponsor Role lead

Responsible Party

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Paolo Pesce

Prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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PAD 4 ospedale san martino

Genova, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Mallet

Identifier Type: -

Identifier Source: org_study_id