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

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

Status: Completed

Conditions: Edentulous; Alveolar Process, Atrophy; Edentulous Alveolar Ridge Atrophy

Treatments: Procedure: sinus lift; Procedure: implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT05500911

ABT2

Details and patient eligibility

About

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 ).

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

NINA- MultiNeO NH

Active Comparator group

Description:

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)

Treatment:

Procedure: implant placement

Procedure: sinus lift

MultiNeO CS

Active Comparator group

Description:

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)

Treatment:

Procedure: implant placement

Procedure: sinus lift