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

September 1, 2024 updated by: Luigi Canullo

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy/Rome
      • Rome, Italy/Rome, Italy, 00198
        • Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NINA- MultiNeO NH
implant with bioactive surface
Procedure: implant placement
implant placement in edentulous area
Active Comparator: MultiNeO CS
implant with traditional surface
Procedure: implant placement
implant placement in edentulous area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after implant placement
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
12 months after implant placement
Implant stability
Time Frame: immediately after implant placement
check implant stability using resonant frequency analysis (RFA)
immediately after implant placement
Implant stability
Time Frame: 30 days after implant placement
check implant stability using resonant frequency analysis (RFA)
30 days after implant placement
Implant stability
Time Frame: 45 days after implant placement
check implant stability using resonant frequency analysis (RFA)
45 days after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During implant placement (T0 baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Canullo

Investigators

  • Principal Investigator: Luigi Canullo, DDS PhD, Studio odontoiatrico associato Cicchese Canullo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Missing Teeth

Clinical Trials on implant placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe