Implant OsteotomyNCT05512273
Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density
A study testing Piezosurgery assisted osteotomy and Conventional drilling osteotomy in people with Implant Osteotomy, run by Hams Hamed Abdelrahman at 1 site in Lebanon.
Trial summary
The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Implant Osteotomy
- What is being tested?
- Piezosurgery assisted osteotomy and Conventional drilling osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2021to 1 Jun 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with bilateral missing premolars
- Remaining bone height more ≥ 10mm.
- Remaining bone width ≥ 6mm
Who cannot join
- patients that smoke more than 10 cigarettes/day
- Patients with uncontrolled systemic disease.
- Presence of bone pathology within the future osteotomy site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density. (Randomized Controlled Clinical Trial- Split Mouth Design)
The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills.
- Conditions
- Implant Osteotomy
- Being tested
- Piezosurgery assisted osteotomy, Conventional drilling osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezosurgery assisted osteotomyProcedure or surgery
Sequential osteotomy drilling was done using mectron piezosurgery implant drilling protocol
Conventional drilling osteotomyProcedure or surgery
bone osteotomy for implant placement was done following the BEGO Semados RS/RSX TrayPlus conventional drilling
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Procedure: Piezosurgery assisted osteotomy |
| Control | Active comparator | Not described Receives: Procedure: Conventional drilling osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of surgery
Average surgical times for implant site was estimated
Measured: through operation completion
Change in implant stability
ISQ was measured using ostell device
Measured: at baseline and 4 months
Change in bone density
Mean bone density using CBCT
Measured: at baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant OsteotomyStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512273
- Sponsor's protocol ID
- Piezosurgery_22
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arakji H, Osman E, Aboelsaad N, Shokry M. Evaluation of implant site preparation with piezosurgery versus conventional drills in terms of operation time, implant stability and bone density (randomized controlled clinical trial- split mouth design). BMC Oral Health. 2022 Dec 3;22(1):567. doi: 10.1186/s12903-022-02613-4.
PubMed 36463145
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density. (Randomized Controlled Clinical Trial- Split Mouth Design)
- ClinicalTrials.gov ID
- NCT05512273
- Acronym / sponsor ID
- Piezosurgery_22
- Conditions
- Implant Osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 23 Aug 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.
The preparation of the implant site has a major influence on the success rate and long-term survival of dental implants. Piezoelectric devices and special implant drilling inserts are now emerging to replace conventional drills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split mouth
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Procedure: Piezosurgery assisted osteotomy |
| Control | Active comparator | Procedure: Conventional drilling osteotomy |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with bilateral missing premolars
- Remaining bone height more ≥ 10mm.
- Remaining bone width ≥ 6mm
Key exclusion criteria (3 listed)
- patients that smoke more than 10 cigarettes/day
- Patients with uncontrolled systemic disease.
- Presence of bone pathology within the future osteotomy site
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 |
|---|---|---|
| Piezosurgery assisted osteotomySequential osteotomy drilling was done using mectron piezosurgery implant drilling protocol | Procedure or surgery | Study |
| Conventional drilling osteotomybone osteotomy for implant placement was done following the BEGO Semados RS/RSX TrayPlus conventional drilling | Procedure or surgery | Control |
Primary outcome
Time of surgery
Time frame: through operation completion
Average surgical times for implant site was estimated
Change in implant stability
Time frame: at baseline and 4 months
ISQ was measured using ostell device
Change in bone density
Time frame: at baseline and 4 months
Mean bone density using CBCT
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 23 Aug 2022.
- Derived from this study: PubMed 36463145Arakji H, Osman E, Aboelsaad N, Shokry M. Evaluation of implant site preparation with piezosurgery versus conventional drills in terms of operation time, implant stability and bone density (randomized controlled clinical trial- split mouth design). BMC Oral Health. 2022 Dec 3;22(1):567. doi: 10.1186/s12903-022-02613-4.
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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 Piezosurgery assisted osteotomy and Conventional drilling osteotomy in people with Implant Osteotomy, run by Hams Hamed Abdelrahman at 1 site in Lebanon.
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 3 inclusion and 3 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 23 Aug 2022. 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 Lebanon. 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?
Time of surgery (time frame: through operation completion). 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?
On the ClinicalTrials.gov record for NCT05512273, which also lists 1 linked publication.
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 23 Aug 2022.