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

Edentulous Alveolar Ridge Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06157047
• Other study ID #: Mallet
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2023
• Source: Universita degli Studi di Genova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 15, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

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.

Locations

Country	Name	City	State
Italy	PAD 4 ospedale san martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Pesce

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone thickness at T0	Thickness of the bone before the surgery measured with cbct and a parodontal probe	Before the surgery
Primary	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
Primary	bone thickness at T2	Thickness of the bone after implant insertion measured with a parodontal probe	Immediately after the implant insertion
Secondary	bone thickness at T3	Thickness of the bone after 3 months from implant insertion measured with a cbct	3 months