Osseodensification Drills Versus Piezoelectric Surgery
Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial
1 other identifier
interventional
27
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedFirst Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedJune 8, 2022
June 1, 2022
10 months
May 31, 2022
June 4, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
implant insertion torque
insertion torque
at implant insertion
implant stability quotient
resonance frequency
at implant insertion
Secondary Outcomes (6)
implant secondary stability
7 days after implant insertion
implant secondary stability
14 days after implant insertion
implant secondary stability
21 days after implant insertion
implant secondary stability
28 days after implant insertion
implant secondary stability
2 months after implant insertion
- +1 more secondary outcomes
Study Arms (2)
8 millimeter implants
EXPERIMENTALimplant insertion with piezo surgical osteotomy and with osseodensification drills
10 millimeter implants
EXPERIMENTALimplant insertion with piezo surgical osteotomy and with osseodensification drills
Interventions
piezoelectric bone surgery osseodensification drills
Eligibility Criteria
You may qualify if:
- bilateral single maxillary edentulism
You may not qualify if:
- smoking habit
- history of periodontal disease
- uncontrolled diabetes
- pregnancy or breastfeeding
- head and neck radiotherapy or chemotherapy
- bone antiresorptive therapy
- coagulopaties
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Piezosurgery Academylead
- University of Foggiacollaborator
- University of Triestecollaborator
Study Sites (2)
Hesire
Cassano Allo Ionio, CS, 87011, Italy
Piezosurgery Academy
Parma, 43100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudio Stacchi, Dr
International Piezoelectric Surgery Academy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- implant stability assessment was blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 8, 2022
Study Start
November 15, 2020
Primary Completion
September 15, 2021
Study Completion
April 15, 2022
Last Updated
June 8, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
no sharing is planned