Edentulous Alveolar RidgeNCT06157047
Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site
A study testing Crestal Bone Expansion obtained with the Magnetic Mallet® in people with Edentulous Alveolar Ridge, run by Paolo Pesce at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Crestal Bone Expansion obtained with the Magnetic Mallet®
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Crestal Bone Expansion obtained with the Magnetic Mallet®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crestal Bone Expansion obtained with the Magnetic Mallet®Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients included | Experimental | Patients' recruitment was guided by their actual need to solve edentulism through the use of implant therapy. The diagnosis was made clinically and radiographically. Receives: Procedure: Crestal Bone Expansion obtained with the Magnetic Mallet® |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone thickness at T0
Thickness of the bone before the surgery measured with cbct and a parodontal probe
Measured: Before the surgery
bone thickness at T1
Thickness of the bone after the use of Magnetic Mallet measured with a parodontal probe
Measured: Immediately after the implant site preparation
bone thickness at T2
Thickness of the bone after implant insertion measured with a parodontal probe
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Oct 2019
- Primary completion31 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolo Pesce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Pesce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157047
- Sponsor's protocol ID
- Mallet
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site
- ClinicalTrials.gov ID
- NCT06157047
- Acronym / sponsor ID
- Mallet
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Paolo PesceUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients included | Experimental | Procedure: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crestal 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. | Procedure or surgery | Patients included |
Primary outcome
bone thickness at T0
Time frame: Before the surgery
Thickness of the bone before the surgery measured with cbct and a parodontal probe
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
bone thickness at T2
Time frame: Immediately after the implant insertion
Thickness of the bone after implant insertion measured with a parodontal probe
1 secondary outcome
bone thickness at T3
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crestal Bone Expansion obtained with the Magnetic Mallet® in people with Edentulous Alveolar Ridge, run by Paolo Pesce at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone thickness at T0 (time frame: Before the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.