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

Study Overview
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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.

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

Conditions
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Edentulous Alveolar Ridge

Intervention / Treatment
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* Procedure: Crestal Bone Expansion obtained with the Magnetic Mallet®


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients included<br>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®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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