Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics
Primary Purpose
Missing Teeth, Edentulous Jaw, Edentulous Mouth
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth focused on measuring dental implant, bioactivation, implant surface
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Studio Odont.Associato Dr.P.Cicchese E L.CanulloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NINA- MultiNeO NH
MultiNeO CS
Arm Description
implant with bioactive surface
implant with traditional surface
Outcomes
Primary Outcome Measures
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
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
Implant stability
check implant stability using resonant frequency analysis (RFA)
Implant stability
check implant stability using resonant frequency analysis (RFA)
Implant stability
check implant stability using resonant frequency analysis (RFA)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05495867
Brief Title
Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics
Official Title
Evaluation of a Bioactive Surface in Post-extraction Sites: Case Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luigi Canullo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth, Edentulous Jaw, Edentulous Mouth
Keywords
dental implant, bioactivation, implant surface
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NINA- MultiNeO NH
Arm Type
Experimental
Arm Description
implant with bioactive surface
Arm Title
MultiNeO CS
Arm Type
Active Comparator
Arm Description
implant with traditional surface
Intervention Type
Procedure
Intervention Name(s)
implant placement
Intervention Description
implant placement in edentulous area
Primary Outcome Measure Information:
Title
Marginal bone loss
Description
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
Time Frame
6 months after implant placement
Title
Marginal bone loss
Description
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
Time Frame
12 months after implant placement
Title
Implant stability
Description
check implant stability using resonant frequency analysis (RFA)
Time Frame
immediately after implant placement
Title
Implant stability
Description
check implant stability using resonant frequency analysis (RFA)
Time Frame
30 days after implant placement
Title
Implant stability
Description
check implant stability using resonant frequency analysis (RFA)
Time Frame
45 days after implant placement
Secondary Outcome Measure Information:
Title
insertion torque curve
Description
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)
Time Frame
During implant placement (T0 baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Canullo, DDS PhD
Phone
+39 06 841 1980
Email
luigicanullo@yahoo.comm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD
Organizational Affiliation
Studio odontoiatrico associato Cicchese Canullo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
City
Rome
State/Province
Italy/Rome
ZIP/Postal Code
00198
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD
Phone
+39 06 841 1980
Email
luigicanullo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
the data will be available for the duration of the study
IPD Sharing Access Criteria
the data will be available for the duration of the study
Citations:
PubMed Identifier
19663964
Citation
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.
Results Reference
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PubMed Identifier
20666787
Citation
Han 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.
Results Reference
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PubMed Identifier
34067747
Citation
Gianfreda 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.
Results Reference
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Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics
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