Missing TeethNCT05495867
Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics
A study testing implant placement in people with Missing Teeth and Edentulous Jaw, run by Luigi Canullo at 1 site in Italy.
Trial summary
In this case-control study a bioactive implant surface was compared with traditional surfaced implants. Primary objectives: Test the implant stability in post-extractive sites, comparing traditional surfaced implants (MultiNeO CS, control group) to bioactive surfaced implants (NINA- MultiNeO NH, treatment group). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth, Edentulous Jaw, Edentulous Mouth
- What is being tested?
- implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2022to 15 Sep 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with type 1-2 post extraction sites
- Subject is 30-80 years old
- Patient ASA 1 or 2
- Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- Patients that are willing to sign an informed consent and participate in a clinical study
Who cannot join
- Absence Type 1-2 post extraction sites
- Patient ASA 3 or 4
- Untreated Periodontitis
- Any sites where an implant already failed sites
- Allergy declared to one or more medicaments to be used during treatment
- Pregnancy (confirmed by verbal inquiry)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Rome, Italy/Rome, 00198
About this study
Official title: Evaluation of a Bioactive Surface in Post-extraction Sites: Case Control Study
In this case-control study a bioactive implant surface was compared with traditional surfaced implants. Primary objectives: Test the implant stability in post-extractive sites, comparing traditional surfaced implants (MultiNeO CS, control group) to bioactive surfaced implants (NINA- MultiNeO NH, treatment group).
Primary outcome endpoints were Implant stability, assessed through Implant stability quotient (ISQ) values and Marginal bone loss (MBL)
Read the detailed description
In this post- market case control study, the tested CE-marked dental implants are MultiNeO CS 1930 and NINA MultiNeO NH 9330, both manufactured by Alpha-Bio Tec. .
Alpha-Bio Tec. implants systems are made of Ti-6AI-4V ELI Titanium alloy which is a high-performance and highly biocompatible alloy for manufacturing bone implants. Alpha-Bio Tec developed the superior NanoTec\&trade implant surface for optimized osseointegration process. Alpha-Bio Tec NanoTec™ implant surface is achieved by a complex process of large particle sandblasting and acid etching. Sandblasting with large particles allows the creation of macropores (20-40 microns), while the double etching allows the creation of micropores (1-5 microns). The micro - structure and roughness properties of NanoTec™ Implant Surface greatly influences the dynamic wettability of implant surfaces during the initial contact with the host.
The overwritten implant surface enables greater absorption of blood and plasma proteins directly inside the micropores, immediately after the implant has been placed.
It is the implant surface of MultiNeO. NeO or MultiNeO is defined as a system since it includes three types of connections: a conical narrow connection (CHC), a conical standard conical connection (CS) and an Internal Hex connection (IH). the fixture has a straight coronal part, a slightly tapered body and a conical apical part. We will use MultiNeO CS in control group. One of the MultiNeO biggest clinical advantages since it is as good at bone type 4 as it is at bone type 1, 2 or 3.
Topography and surface roughness of MultiNeO lead to some clinical advantages:
Increased early BIC; Increased primary and secondary stability; Shortened healing period; Accelerated and improved osseointegration process.
MultiNeO CS has an implant surface similar to the aforementioned SLA surface manufactured by Straumann. In fact, SLA is a sub-micron scale roughness created by Aluminum oxide blasting and double acid etching.
NINA- MultiNeO NH is used for treatment group, and it is being tested. NINA MultiNeO NH has got an innovative bioactive surface.
NINA MultiNeO NH surface is a combination of the abovementioned roughening process and the creation of titanium oxide nano structure. Its hydrophilic part is created by resorbable salt thus maintaining its hydrophilicity.
Although a variety of implant surface are available for implant rehabilitation, the first hypothesis is that NINA MultiNeO NH Alpha-Bio Tec ® will be positively adopted for rehabilitation of missing teeth with shorter healing time and less marginal bone loss.
The idea behind these studies is to maximize the effect of the bioactive surface testing its behavior in a poor host environment with a reduced time
- Conditions
- Missing Teeth, Edentulous Jaw, Edentulous Mouth
- Being tested
- implant placement
- Keywords
- dental implant, bioactivation, implant surface
- Medical subject headings
- Anodontia, Jaw, Edentulous, Mouth, Edentulous
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 in edentulous area
| Study group | Role | What they receive |
|---|---|---|
| NINA- MultiNeO NH | Experimental | implant with bioactive surface Receives: Procedure: implant placement |
| MultiNeO CS | Active comparator | implant with traditional surface Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost
Measured: 6 months after implant placement
Marginal bone loss
Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost
Measured: 12 months after implant placement
Implant stability
check implant stability using resonant frequency analysis (RFA)
Measured: immediately after implant placement
Implant stability
check implant stability using resonant frequency analysis (RFA)
Measured: 30 days after implant placement
Implant stability
check implant stability using resonant frequency analysis (RFA)
Measured: 45 days after implant placement
Secondary outcomes (1)
insertion torque curve
The Insertion torque data were recorded and exported as a curve The torque curve records the amount of energy that was needed for arrive at the positioning of the implant.
unit of measurement of torque is Newton centimeter (Ncm)
Measured: During implant placement (T0 baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start22 Apr 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luigi Canullo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Investigators
- Luigi Canullo, DDS PhD, Principal investigator, Studio odontoiatrico associato Cicchese Canullo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495867
- Sponsor's protocol ID
- ABT1
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data will be first recorded in EDC (electronic data capture). Then data will be entered into one-central computerized database. Patient adverse events will be reported, including during implant placement and throughout follow-up period. Implant details parameters and data will be recorded into EDC. The data then will be entered into one central computerized database and analyzed statistically for evaluation of the results. The study database will be designed and maintained using Microsoft Excel. an identification code will be assigned to each patient
Publications
Wennerberg A, Albrektsson T. Effects of titanium surface topography on bone integration: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:172-84. doi: 10.1111/j.1600-0501.2009.01775.x.
PubMed 19663964Han J, Lulic M, Lang NP. Factors influencing resonance frequency analysis assessed by Osstell mentor during implant tissue integration: II. Implant surface modifications and implant diameter. Clin Oral Implants Res. 2010 Jun;21(6):605-11. doi: 10.1111/j.1600-0501.2009.01909.x.
PubMed 20666787Gianfreda F, Antonacci D, Raffone C, Muzzi M, Pistilli V, Bollero P. Microscopic Characterization of Bioactivate Implant Surfaces: Increasing Wettability Using Salts and Dry Technology. Materials (Basel). 2021 May 17;14(10):2608. doi: 10.3390/ma14102608.
PubMed 34067747
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Bioactive Surface in Post-extraction Sites: Case Control Study
- ClinicalTrials.gov ID
- NCT05495867
- Acronym / sponsor ID
- ABT1
- Conditions
- Missing Teeth, Edentulous Jaw, Edentulous Mouth
- Keywords
- dental implant, bioactivation, implant surface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Luigi CanulloUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 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.
In this case-control study a bioactive implant surface was compared with traditional surfaced implants. Primary objectives: Test the implant stability in post-extractive sites, comparing traditional surfaced implants (MultiNeO CS, control group) to bioactive surfaced implants (NINA- MultiNeO NH, treatment group).
Primary outcome endpoints were Implant stability, assessed through Implant stability quotient (ISQ) values and Marginal bone loss (MBL)
Detailed description
In this post- market case control study, the tested CE-marked dental implants are MultiNeO CS 1930 and NINA MultiNeO NH 9330, both manufactured by Alpha-Bio Tec. .
Alpha-Bio Tec. implants systems are made of Ti-6AI-4V ELI Titanium alloy which is a high-performance and highly biocompatible alloy for manufacturing bone implants. Alpha-Bio Tec developed the superior NanoTec\&trade implant surface for optimized osseointegration process. Alpha-Bio Tec NanoTec™ implant surface is achieved by a complex process of large particle sandblasting and acid etching. Sandblasting with large particles allows the creation of macropores (20-40 microns), while the double etching allows the creation of micropores (1-5 microns). The micro - structure and roughness properties of NanoTec™ Implant Surface greatly influences the dynamic wettability of implant surfaces during the initial contact with the host.
The overwritten implant surface enables greater absorption of blood and plasma proteins directly inside the micropores, immediately after the implant has been placed.
It is the implant surface of MultiNeO. NeO or MultiNeO is defined as a system since it includes three types of connections: a conical narrow connection (CHC), a conical standard conical connection (CS) and an Internal Hex connection (IH). the fixture has a straight coronal part, a slightly tapered body and a conical apical part. We will use MultiNeO CS in control group. One of the MultiNeO biggest clinical advantages since it is as good at bone type 4 as it is at bone type 1, 2 or 3.
Topography and surface roughness of MultiNeO lead to some clinical advantages:
Increased early BIC; Increased primary and secondary stability; Shortened healing period; Accelerated and improved osseointegration process.
MultiNeO CS has an implant surface similar to the aforementioned SLA surface manufactured by Straumann. In fact, SLA is a sub-micron scale roughness created by Aluminum oxide blasting and double acid etching.
NINA- MultiNeO NH is used for treatment group, and it is being tested. NINA MultiNeO NH has got an innovative bioactive surface.
NINA MultiNeO NH surface is a combination of the abovementioned roughening process and the creation of titanium oxide nano structure. Its hydrophilic part is created by resorbable salt thus maintaining its hydrophilicity.
Although a variety of implant surface are available for implant rehabilitation, the first hypothesis is that NINA MultiNeO NH Alpha-Bio Tec ® will be positively adopted for rehabilitation of missing teeth with shorter healing time and less marginal bone loss.
The idea behind these studies is to maximize the effect of the bioactive surface testing its behavior in a poor host environment with a reduced time
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NINA- MultiNeO NH | Experimental | Procedure: implant placementimplant with bioactive surface |
| MultiNeO CS | Active comparator | Procedure: implant placementimplant with traditional surface |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with type 1-2 post extraction sites
- Subject is 30-80 years old
- Patient ASA 1 or 2
- Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- Patients that are willing to sign an informed consent and participate in a clinical study
Key exclusion criteria (6 listed)
- Absence Type 1-2 post extraction sites
- Patient ASA 3 or 4
- Untreated Periodontitis
- Any sites where an implant already failed sites
- Allergy declared to one or more medicaments to be used during treatment
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 in edentulous area | Procedure or surgery | MultiNeO CS, NINA- MultiNeO NH |
Primary outcome
Marginal bone loss
Time frame: 6 months after implant placement
Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost
Marginal bone loss
Time frame: 12 months after implant placement
Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost
Implant stability
Time frame: immediately after implant placement
check implant stability using resonant frequency analysis (RFA)
Implant stability
Time frame: 30 days after implant placement
check implant stability using resonant frequency analysis (RFA)
Implant stability
Time frame: 45 days after implant placement
check implant stability using resonant frequency analysis (RFA)
1 secondary outcome
insertion torque curve
Time frame: During implant placement (T0 baseline)
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 4 Sep 2024.
- Background: PubMed 19663964Wennerberg A, Albrektsson T. Effects of titanium surface topography on bone integration: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:172-84. doi: 10.1111/j.1600-0501.2009.01775.x.
- Background: PubMed 20666787Han J, Lulic M, Lang NP. Factors influencing resonance frequency analysis assessed by Osstell mentor during implant tissue integration: II. Implant surface modifications and implant diameter. Clin Oral Implants Res. 2010 Jun;21(6):605-11. doi: 10.1111/j.1600-0501.2009.01909.x.
- Background: PubMed 34067747Gianfreda F, Antonacci D, Raffone C, Muzzi M, Pistilli V, Bollero P. Microscopic Characterization of Bioactivate Implant Surfaces: Increasing Wettability Using Salts and Dry Technology. Materials (Basel). 2021 May 17;14(10):2608. doi: 10.3390/ma14102608.
- Individual participant dataSharing planned: Yes. Clinical data will be first recorded in EDC (electronic data capture). Then data will be entered into one-central computerized database. Patient adverse events will be reported, including during implant placement and throughout follow-up period. Implant details parameters and data will be recorded into EDC. The data then will be entered into one central computerized database and analyzed statistically for evaluation of the results. The study database will be designed and maintained using Microsoft Excel. an identification code will be assigned to each patient
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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.
Luigi Canullo, DDS PhD principal investigator
Studio odontoiatrico associato Cicchese Canullo
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 Missing Teeth and Edentulous Jaw, run by Luigi Canullo 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 5 inclusion and 6 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 4 Sep 2024. 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?
Marginal bone loss (time frame: 6 months after implant placement). The study lists 5 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 NCT05495867, which also lists 3 linked publications.
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 4 Sep 2024.