CClinicalTrials.gg
CompletedNCT06157047Updated Dec 5, 2023

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

An interventional study of Crestal Bone Expansion obtained with the Magnetic Mallet® in Edentulous Alveolar Ridge, sponsored by Paolo Pesce. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Paolo Pesce · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Oct 2019, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edentulous Alveolar Ridge

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03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's enrollment of 15 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

Paolo Pesce is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Patients included

    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

  • 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.

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What researchers measure

Primary outcomes

  1. bone thickness at T0

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

    Time frame: Before the surgery

  2. bone thickness at T1

    Thickness of the bone after the use of Magnetic Mallet measured with a parodontal probe

    Time frame: Immediately after the implant site preparation

  3. bone thickness at T2

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

    Time frame: Immediately after the implant insertion

Secondary outcomes

  1. bone thickness at T3

    Thickness of the bone after 3 months from implant insertion measured with a cbct

    Time frame: 3 months

07

Study locations

1 site
  • PAD 4 ospedale san martino
    Genova, 16132, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06157047
Lead sponsor
Paolo Pesce
Responsible party
Paolo Pesce (Prof, Universita degli Studi di Genova) — Sponsor-investigator
First posted
Dec 5, 2023
Start date
Oct 1, 2019
Primary completion
May 31, 2022
Completion
Jul 15, 2022
Last update
Dec 5, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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