Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultaneous Sinus Lift

August 11, 2022 updated by: Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Evaluation of a Bioactive Surface in Posterior Maxillary Sites: Controlled Clinical Trial

In this controlled clinical study, a maxillary sinus lift (crestal approach) with OSSIX® Bone will be performed, and then implants MultiNeO CS (control group) and NINA MultiNeO NH (test group) will be inserted in edentulous posterior maxillae of study subjects. .+the clinical and radiographic results of the rehabilitation of posterior edentulous maxillary areas, obtained with traditional surface implants (MultiNeO CS, control group), are compared with those obtained with bioactive surface implants (NINA - MultiNeO NH, test group ).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this post- market controlled clinical study, the tested CE-marked dental implants are MultiNeO CS 1930 and NINA MultiNeO NH 9330, both manufactured by Alpha-Bio Tec. 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 to treat control group. One of the MultiNeO CS biggest clinical advantages since it is as good at bone type 4 as it is at bone type 1, 2 or 3.

MultiNeO CS has an implant surface with a sub-micron scale roughness created by Aluminum oxide blasting and double acid etching.

NINA MultiNeO NH is used for tret group, it 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 Patient requiring sinus floor elevation with native bone crest height > 4 mm will be enrolled.Although a variety of implant surface are available for implant supported rehabilitation, the first hypothesis is that NINA MultiNeO NH Alpha-Bio Tec will be present faster osteointegration time compared to MultiNeO CS when adopted to rehabilitate of missing teeth in case of critical areas such as in the posterior mandible with critical bone defects. The second hypothesis is that NINA MultiNeO NH will promote a better apical bone regeneration in patients treated with sinus lift compared to MultiNeO CS due to its bioactive surface.

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Locations

  • Italy
    • Italy/Rome
      • Rome, Italy/Rome, Italy, 00198
        • Recruiting
        • Studio Odont.Associato Dr.P.Cicchese E L.Canullo
        • Contact:
        • Principal Investigator:
          • Luigi Canullo, DDS PhD

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

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • edentulous posterior maxillae
  • residual bone height > 4mm
  • healthy periodontal conditions

Exclusion Criteria:

  • smokers over 5 cigarettes/day
  • Pregnancy (confirmed by verbal inquiry)
  • Chronic systemic pathologies and neoplastic of the Oro-Facial District
  • bisphosphonates intake
  • Any sites where an implant already failed sites
  • Untreated Periodontitis
  • Sites with acute infections
  • Chronic inflammatory diseases of the oral cavity
  • Autoimmune diseases (cortisone intake)
  • Allergy declared to one or more medicaments to be used during treatment
  • Alcoholics patients and/or drug addicts
  • collagen hypersensitivity.

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
Active Comparator: NINA- MultiNeO NH
After the sinus lift procedure (performed with OSSIX® BONE on all study subjects) treatment group will be treated with a bioactive surfaced implant (NINA MultiNeO NH)
Procedure: sinus lift
when residual bone height is >4 mm sinus lift through crestal approach procedure will be performed and after sinus flor elevation, OSSIX® Bone will be placed in the sinus cavity.
Other Names:
  • sinus floor elevation
Procedure: implant placement
Implant will be placed in edentulous area
Active Comparator: MultiNeO CS
After the sinus lift procedure (performed with OSSIX® BONE on all study subjects) control group will be treated with a traditional implant surface (MultiNeO CS)
Procedure: sinus lift
when residual bone height is >4 mm sinus lift through crestal approach procedure will be performed and after sinus flor elevation, OSSIX® Bone will be placed in the sinus cavity.
Other Names:
  • sinus floor elevation
Procedure: implant placement
Implant will be placed 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 marginal 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 marginal 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) Resonance frequency analysis (RFA) provides objective measurements of implant stability in a non-invasive way on the bone-implant interface. The results of the resonance frequency analysis are transformed into implant stability quotient (ISQ) values. ISQ, implant stability quotient, depends on the transducer used and is recorded as a number between 1 and 100, 100 representing the highest degree of stability. Transducers are designed for specific implant types and calibrated by the manufacturer.
immediately after implant placement
Implant stability
Time Frame: 2 months after implant placement
Resonance frequency analysis (RFA) provides objective measurements of implant stability in a non-invasive way on the bone-implant interface. The results of the resonance frequency analysis are transformed into implant stability quotient (ISQ) values. ISQ, implant stability quotient, depends on the transducer used and is recorded as a number between 1 and 100, 100 representing the highest degree of stability. Transducers are designed for specific implant types and calibrated by the manufacturer.
2 months after implant placement
Implant stability
Time Frame: 4 months after implant placement
Resonance frequency analysis (RFA) provides objective measurements of implant stability in a non-invasive way on the bone-implant interface. The results of the resonance frequency analysis are transformed into implant stability quotient (ISQ) values. ISQ, implant stability quotient, depends on the transducer used and is recorded as a number between 1 and 100, 100 representing the highest degree of stability. Transducers are designed for specific implant types and calibrated by the manufacturer.
4 months after implant placement
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apical Bone regeneration
Time Frame: 6 months after implant placement
Apical bone regeneration is calculated by the difference in volume between CBCT at baseline and 6 months follow-up
6 months after implant placement
Evaluation the effects of bioactive implant surface (NINA- MultiNeO NH) in Apical Bone regeneration performed under the schneiderian membrane lining the maxillary sinus. Apical Bone regeneration defines the osseoinductive potential of a surface.
Time Frame: 12 months after implant placement
Apical bone regeneration is calculated by the difference in volume between CBCT at baseline and 6 months follow-up
12 months after implant placement

Collaborators and Investigators

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

Sponsor

Studio Odontoiatrico Associato Dr. P. Cicchese e L. 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 (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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