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

December 3, 2023 updated by: Paolo Pesce
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • PAD 4 ospedale san martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone thickness at T0
Time Frame: Before the surgery
Thickness of the bone before the surgery measured with cbct and a parodontal probe
Before the surgery
bone thickness at T1
Time Frame: Immediately after the implant site preparation
Thickness of the bone after the use of Magnetic Mallet measured with a parodontal probe
Immediately after the implant site preparation
bone thickness at T2
Time Frame: Immediately after the implant insertion
Thickness of the bone after implant insertion measured with a parodontal probe
Immediately after the implant insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone thickness at T3
Time Frame: 3 months
Thickness of the bone after 3 months from implant insertion measured with a cbct
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paolo Pesce

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

December 3, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mallet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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