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

Not Applicable

Completed

• Conditions: Edentulous Alveolar Ridge
• Interventions: Procedure: Crestal Bone Expansion obtained with the Magnetic Mallet®

• Registration Number: NCT06157047
• Lead Sponsor: Paolo Pesce

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.

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 Timeline

• Study Start: 2019-10-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-07-15
• Study First Submitted: 2023-11-13
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-03
• Last Update Submitted: 2023-12-03
• Study First Posted: 2023-12-05
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients included	Crestal Bone Expansion obtained with the Magnetic Mallet®	Patients' recruitment was guided by their actual need to solve edentulism through the use of implant therapy. The diagnosis was made clinically and radiographically.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
bone thickness at T3	3 months	Thickness of the bone after 3 months from implant insertion measured with a cbct

Trial Locations

Locations (1)

PAD 4 ospedale san martino; 🇮🇹 Genova, Italy