Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics

Edentulous Jaw Clinical Trial

Official title:

Evaluation of a Bioactive Surface in Post-extraction Sites: Case Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495867
• Other study ID #: ABT1
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: August 2022
• Source: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Contact: Luigi Canullo, DDS PhD
• Phone: +39 06 841 1980
• Email: luigicanullo[@]yahoo.comm
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Primary outcome endpoints were Implant stability, assessed through Implant stability quotient (ISQ) values and Marginal bone loss (MBL)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient with type 1-2 post extraction sites

2. Subject is 30-80 years old

3. Patient ASA 1 or 2

4. Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)

5. Patients that are willing to sign an informed consent and participate in a clinical study

Exclusion Criteria:

1. Absence Type 1-2 post extraction sites

2. Patient ASA 3 or 4

3. Untreated Periodontitis

4. Any sites where an implant already failed sites

5. Allergy declared to one or more medicaments to be used during treatment

6. Pregnancy (confirmed by verbal inquiry)

Related Conditions & MeSH terms

• Anodontia
• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Missing Teeth
• Mouth, Edentulous
• Tooth Loss

Intervention

Procedure:
• implant placement
implant placement in edentulous area

Locations

Country	Name	City	State
Italy	Studio Odont.Associato Dr.P.Cicchese E L.Canullo	Rome	Italy/Rome

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Canullo

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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). pii: 2608. doi: 10.3390/ma14102608. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months after implant placement
Primary	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	12 months after implant placement
Primary	Implant stability	check implant stability using resonant frequency analysis (RFA)	immediately after implant placement
Primary	Implant stability	check implant stability using resonant frequency analysis (RFA)	30 days after implant placement
Primary	Implant stability	check implant stability using resonant frequency analysis (RFA)	45 days after implant placement
Secondary	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)	During implant placement (T0 baseline)