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OpenTrials
Completed

NCT Number: NCT06157047

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

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.

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Key information

Conditions

Edentulous Alveolar Ridge

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAD 4 ospedale san martino

Genova, 16132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crestal Bone Expansion obtained with the Magnetic Mallet®

Procedure

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.

Primary outcomes

  1. bone thickness at T0

    Time frame: Before the surgery

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

  2. bone thickness at T1

    Time frame: Immediately after the implant site preparation

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

  3. bone thickness at T2

    Time frame: Immediately after the implant insertion

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

Secondary outcomes

  1. bone thickness at T3

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Paolo Pesce

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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