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

NCT ID: NCT05500911

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2024-05-10

Brief Summary

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 ).

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.

Conditions

Edentulous; Alveolar Process, Atrophy; Edentulous Alveolar Ridge Atrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

sinus lift

Intervention Type: 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.

implant placement

Intervention Type: PROCEDURE

Implant will be placed in edentulous area

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)

Group Type: ACTIVE_COMPARATOR

sinus lift

Intervention Type: 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.

implant placement

Intervention Type: PROCEDURE

Implant will be placed in edentulous area

Interventions

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.

Intervention Type: PROCEDURE

implant placement

Implant will be placed in edentulous area

Intervention Type: PROCEDURE

Other Intervention Names

sinus floor elevation

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Luigi Canullo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rome, Italy/Rome, Italy

Countries

Italy

References

Gittens RA, Scheideler L, Rupp F, Hyzy SL, Geis-Gerstorfer J, Schwartz Z, Boyan BD. A review on the wettability of dental implant surfaces II: Biological and clinical aspects. Acta Biomater. 2014 Jul;10(7):2907-18. doi: 10.1016/j.actbio.2014.03.032. Epub 2014 Apr 5.

Reference Type: BACKGROUND

PMID: 24709541 (View on PubMed)

Han J, Lulic M, Lang NP. Factors influencing resonance frequency analysis assessed by Osstell mentor during implant tissue integration: II. Implant surface modifications and implant diameter. Clin Oral Implants Res. 2010 Jun;21(6):605-11. doi: 10.1111/j.1600-0501.2009.01909.x.

Reference Type: BACKGROUND

PMID: 20666787 (View on PubMed)

Oates TW, Valderrama P, Bischof M, Nedir R, Jones A, Simpson J, Toutenburg H, Cochran DL. Enhanced implant stability with a chemically modified SLA surface: a randomized pilot study. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):755-60.

Reference Type: BACKGROUND

PMID: 17974109 (View on PubMed)

Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.

Reference Type: BACKGROUND

PMID: 25123761 (View on PubMed)

Stacchi C, Lombardi T, Ottonelli R, Berton F, Perinetti G, Traini T. New bone formation after transcrestal sinus floor elevation was influenced by sinus cavity dimensions: A prospective histologic and histomorphometric study. Clin Oral Implants Res. 2018 May;29(5):465-479. doi: 10.1111/clr.13144. Epub 2018 Mar 23.

Reference Type: BACKGROUND

PMID: 29569763 (View on PubMed)

Other Identifiers

ABT2

Identifier Type: -

Identifier Source: org_study_id