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OpenTrials
Completed

NCT Number: NCT05495867

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

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)

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Rome, Italy/Rome, 00198, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

implant placement

Procedure

implant placement in edentulous area

Primary outcomes

  1. 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

  2. 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

  3. Implant stability

    Time frame: immediately after implant placement

    check implant stability using resonant frequency analysis (RFA)

  4. Implant stability

    Time frame: 30 days after implant placement

    check implant stability using resonant frequency analysis (RFA)

  5. Implant stability

    Time frame: 45 days after implant placement

    check implant stability using resonant frequency analysis (RFA)

Secondary outcomes

  1. insertion torque curve

    Time frame: During implant placement (T0 baseline)

    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)

Sponsors and collaborators

Lead sponsor

Luigi Canullo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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