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

NCT06157047 | Completed

• 1 other identifier: Mallet
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (3)

• bone thickness at T0

  Thickness of the bone before the surgery measured with cbct and a parodontal probe

  Before the surgery

• bone thickness at T1

  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

  Thickness of the bone after implant insertion measured with a parodontal probe

  Immediately after the implant insertion

Secondary Outcomes (1)

• bone thickness at T3

  3 months

Study Arms (1)

Patients included

EXPERIMENTAL

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®

Interventions

Crestal Bone Expansion obtained with the Magnetic Mallet® 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.

Patients included

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paolo Pesce: lead

Study Sites (1)

PAD 4 ospedale san martino

Genova, 16132, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 5, 2023
• Study Start: October 1, 2019
• Primary Completion: May 31, 2022
• Study Completion: July 15, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)