Clinical trial NCT05500911: Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultaneous Sinus Lift
Official title: Evaluation of a Bioactive Surface in Posterior Maxillary Sites: Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Edentulous Alveolar Ridge Atrophy
Keywords: dental implant
implant surface
sinus lift
sinus floor elevation
Lead sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model 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), test group will be treated with a bioactive surfaced implant (NINA MultiNeO NH)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Marginal bone change
timeFrame: 6 months after implant placement
measure: Marginal bone change
timeFrame: 12 months after implant placement
measure: Implant stability
timeFrame: immediately after implant placement
measure: Implant stability
timeFrame: 2 months after implant placement
measure: Implant stability
timeFrame: 4 months after implant placement
measure: insertion torque curve
timeFrame: During implant placement (T0 baseline
Secondary outcomes:
measure: Apical Bone regeneration
timeFrame: 6 months after implant placement
measure: 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.
timeFrame: 12 months after implant placement
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Studio Odont.Associato Dr.P.Cicchese E L.Canullo
state: Italy/Rome
Study officials:
References:
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citation: 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.
citation: 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.
citation: Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.
citation: 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.