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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: sinus lift
* Procedure: implant placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NINA- MultiNeO NH<br>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<br>* 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.<br>* Other names: sinus floor elevation;Procedure: implant placement<br>* Implant will be placed in edentulous area<br>|
| Active Comparator: MultiNeO CS<br>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<br>* 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.<br>* Other names: sinus floor elevation;Procedure: implant placement<br>* Implant will be placed in edentulous area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Apical bone regeneration is calculated by the difference in volume between CBCT at baseline and 6 months follow-up | 12 months after implant placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, implant surface, sinus lift, sinus floor elevation