Implant GeometryNCT05558800
Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.
A study testing Implant placement in people with Implant Geometry, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Geometry
- What is being tested?
- Implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2018to 30 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.
- Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
- Healed bone crest (≥ 3 months elapsed after extraction or tooth loss).
- Age > 18 years.
- Ability to examine and fully understand the study protocol.
Who cannot join
- • Myocardial infarction within the past 6 months.
- Poorly controlled diabetes (HBA1c > 7.5%).
- Coagulation disorders.
- Radiotherapy to the head/neck area within the past two years.
- Present or past treatment with intravenous bisphosphonates.
- Immunocompromised patients.
Show all 10Show fewer
- Psychological or psychiatric problems.
- Alcohol or drug abuse.
- Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%).
- Uncontrolled periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.
- Conditions
- Implant Geometry
- Being tested
- Implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementProcedure or surgery
Implant placement with different surface types
| Study group | Role | What they receive |
|---|---|---|
| Xpeed | Active comparator | Implant with Xpeed surface Receives: Procedure: Implant placement |
| SLA surface | Active comparator | Implant with SLA surface Receives: Procedure: Implant placement |
| Machined | Placebo comparator | Implant with machined surface Receives: Procedure: Implant placement |
| XPEEDActive | Active comparator | Implant with plasma treatment reactivated XPEED implant surface Receives: Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone to implant contact
Histology technique on specimen retrieved containing mini-implants and bone surrounding it
Measured: 4 weeks healing period after implant placement
Bone to implant contact
Histology technique on specimen retrieved containing mini-implants and bone surrounding it
Measured: 6 weeks healing period after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jan 2018
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant GeometryStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Makari, Saint-Joseph University
- Investigators
- Christian Makary, Phd, Principal investigator, Saint Joseph University - Beirut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558800
- Sponsor's protocol ID
- XFMD171
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.
- ClinicalTrials.gov ID
- NCT05558800
- Acronym / sponsor ID
- XFMD171
- Conditions
- Implant Geometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 28 Sep 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.
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Xpeed | Active comparator | Procedure: Implant placementImplant with Xpeed surface |
| SLA surface | Active comparator | Procedure: Implant placementImplant with SLA surface |
| Machined | Placebo comparator | Procedure: Implant placementImplant with machined surface |
| XPEEDActive | Active comparator | Procedure: Implant placementImplant with plasma treatment reactivated XPEED implant surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.
Key exclusion criteria (10 listed)
- • Myocardial infarction within the past 6 months.
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 placementImplant placement with different surface types | Procedure or surgery | Machined, SLA surface, XPEEDActive, Xpeed |
Primary outcome
Bone to implant contact
Time frame: 4 weeks healing period after implant placement
Histology technique on specimen retrieved containing mini-implants and bone surrounding it
Bone to implant contact
Time frame: 6 weeks healing period after implant placement
Histology technique on specimen retrieved containing mini-implants and bone surrounding it
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 30 Nov 2023.
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.
Christian Makary, Phd principal investigator
Saint Joseph University - Beirut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement in people with Implant Geometry, run by Saint-Joseph University 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 5 inclusion and 10 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 30 Nov 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 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. Some participants in this study may receive a placebo. 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 to implant contact (time frame: 4 weeks healing period after implant placement). 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 30 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.