Edentulous; Alveolar Process, AtrophyNCT05410405
Osseodensification Drills Versus Piezoelectric Surgery
A study testing implant site preparation in people with Edentulous; Alveolar Process, Atrophy, run by International Piezosurgery Academy at 2 sites in Italy.
Trial summary
implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous; Alveolar Process, Atrophy
- What is being tested?
- implant site preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Nov 2020to 15 Apr 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
- bilateral single maxillary edentulism
Who cannot join
- smoking habit
- history of periodontal disease
- uncontrolled diabetes
- pregnancy or breastfeeding
- head and neck radiotherapy or chemotherapy
- bone antiresorptive therapy
- coagulopaties
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Hesire
Cassano Allo Ionio, CS, 87011
Piezosurgery Academy
Parma, 43100
About this study
Official title: Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial
implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.
Read the detailed description
Impianti stability represents one of the most fundamental issue for implant success. Different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. Due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills.
Patients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Being tested
- implant site preparation
- Medical subject headings
- Mouth, Edentulous, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant site preparationProcedure or surgery
Also called implant insertion
piezoelectric bone surgery osseodensification drills
| Study group | Role | What they receive |
|---|---|---|
| 8 millimeter implants | Experimental | implant insertion with piezo surgical osteotomy and with osseodensification drills Receives: Procedure: implant site preparation |
| 10 millimeter implants | Experimental | implant insertion with piezo surgical osteotomy and with osseodensification drills Receives: Procedure: implant site preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant insertion torque
insertion torque
Measured: at implant insertion
implant stability quotient
resonance frequency
Measured: at implant insertion
Secondary outcomes (6)
implant secondary stability
resonance frequency
Measured: 7 days after implant insertion
implant secondary stability
resonance frequency
Measured: 14 days after implant insertion
implant secondary stability
resonance frequency
Measured: 21 days after implant insertion
implant secondary stability
resonance frequency
Measured: 28 days after implant insertion
implant secondary stability
resonance frequency
Measured: 2 months after implant insertion
implant secondary stability
resonance frequency
Measured: 3 months after implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Nov 2020
- Primary completion15 Sep 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous; Alveolar Process, AtrophyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Foggia, University of Trieste
- Responsible party
- Sponsor
- Investigators
- Claudio Stacchi, Dr, Study director, International Piezoelectric Surgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410405
- Sponsor's protocol ID
- piezodensi
- Status last verified
- Jun 2022
- First submitted
- 31 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing is planned
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05410405
- Acronym / sponsor ID
- piezodensi
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Collaborators
- University of Foggia, University of Trieste
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 8 Jun 2022 (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.
implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.
Detailed description
Impianti stability represents one of the most fundamental issue for implant success. Different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. Due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills.
Patients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| 8 millimeter implants | Experimental | Procedure: implant site preparationimplant insertion with piezo surgical osteotomy and with osseodensification drills |
| 10 millimeter implants | Experimental | Procedure: implant site preparationimplant insertion with piezo surgical osteotomy and with osseodensification drills |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral single maxillary edentulism
Key exclusion criteria (7 listed)
- smoking habit
- history of periodontal disease
- uncontrolled diabetes
- pregnancy or breastfeeding
- head and neck radiotherapy or chemotherapy
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 |
|---|---|---|
| implant site preparationAlso: implant insertionpiezoelectric bone surgery osseodensification drills | Procedure or surgery | 10 millimeter implants, 8 millimeter implants |
Primary outcome
implant insertion torque
Time frame: at implant insertion
insertion torque
implant stability quotient
Time frame: at implant insertion
resonance frequency
6 secondary outcomes
implant secondary stability
Time frame: 7 days after implant insertion
implant secondary stability
Time frame: 14 days after implant insertion
implant secondary stability
Time frame: 21 days after implant insertion
implant secondary stability
Time frame: 28 days after implant insertion
implant secondary stability
Time frame: 2 months after implant insertion
implant secondary stability
Time frame: 3 months after implant insertion
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 8 Jun 2022.
- Individual participant dataSharing planned: No. no sharing is planned
Related trials for Edentulous; Alveolar Process, Atrophy
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
Recruiting
Graftless TSFE Via Self-tapping Implants
Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization
Active, not recruiting
Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles
Prosthodontics, Implants, Dental
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.
Claudio Stacchi, Dr study director
International Piezoelectric Surgery Academy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant site preparation in people with Edentulous; Alveolar Process, Atrophy, run by International Piezosurgery Academy at 2 sites 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 1 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
implant insertion torque (time frame: at implant insertion). The study lists 2 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 8 Jun 2022.