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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06157047
Enrollment
15
Registered
2023-12-05
Start date
2019-10-01
Completion date
2022-07-15
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Alveolar Ridge

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.

Interventions

PROCEDURECrestal 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.

Sponsors

Paolo Pesce
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
bone thickness at T0Before the surgeryThickness of the bone before the surgery measured with cbct and a parodontal probe
bone thickness at T1Immediately after the implant site preparationThickness of the bone after the use of Magnetic Mallet measured with a parodontal probe
bone thickness at T2Immediately after the implant insertionThickness of the bone after implant insertion measured with a parodontal probe

Secondary

MeasureTime frameDescription
bone thickness at T33 monthsThickness of the bone after 3 months from implant insertion measured with a cbct

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026