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Completed

NCT Number: NCT05500911

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

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 ).

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Key information

Conditions

Edentulous; Alveolar Process, Atrophy Atrophy Edentulous Alveolar Ridge Atrophy Mouth Diseases Mouth, Edentulous Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

30 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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

sinus lift

Procedure

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

implant placement

Procedure

Implant will be placed in edentulous area

Primary outcomes

  1. Marginal bone change

    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

  2. Marginal bone change

    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

  3. 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.

  4. 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.

  5. 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.

  6. 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)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2022
Registry last updated
May 16, 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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