Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultaneous Sinus Lift
Primary Purpose
Edentulous; Alveolar Process, Atrophy, Edentulous Alveolar Ridge Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sinus lift
implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous; Alveolar Process, Atrophy focused on measuring dental implant, implant surface, sinus lift, 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.
Sites / Locations
- Studio Odont.Associato Dr.P.Cicchese E L.CanulloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NINA- MultiNeO NH
MultiNeO CS
Arm 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)
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)
Outcomes
Primary Outcome Measures
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
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
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.
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.
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.
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)
Secondary Outcome Measures
Apical Bone regeneration
Apical bone regeneration is calculated by the difference in volume between CBCT at baseline and 6 months follow-up
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
Full Information
NCT ID
NCT05500911
First Posted
August 10, 2022
Last Updated
August 11, 2022
Sponsor
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
1. Study Identification
Unique Protocol Identification Number
NCT05500911
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous; Alveolar Process, Atrophy, Edentulous Alveolar Ridge Atrophy
Keywords
dental implant, implant surface, sinus lift, sinus floor elevation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NINA- MultiNeO NH
Arm Type
Active Comparator
Arm 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)
Arm Title
MultiNeO CS
Arm Type
Active Comparator
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
sinus lift
Other Intervention Name(s)
sinus floor elevation
Intervention Description
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
Intervention Name(s)
implant placement
Intervention Description
Implant will be placed in edentulous area
Primary Outcome Measure Information:
Title
Marginal bone loss
Description
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
Time Frame
6 months after implant placement
Title
Marginal bone loss
Description
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
Time Frame
12 months after implant placement
Title
Implant stability
Description
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.
Time Frame
immediately after implant placement
Title
Implant stability
Description
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.
Time Frame
2 months after implant placement
Title
Implant stability
Description
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.
Time Frame
4 months after implant placement
Title
insertion torque curve
Description
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)
Time Frame
During implant placement (T0 baseline
Secondary Outcome Measure Information:
Title
Apical Bone regeneration
Description
Apical bone regeneration is calculated by the difference in volume between CBCT at baseline and 6 months follow-up
Time Frame
6 months after implant placement
Title
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.
Description
Apical bone regeneration is calculated by the difference in volume between CBCT at baseline and 6 months follow-up
Time Frame
12 months after implant placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Canullo, DDS PhD
Phone
3476201976
Email
luigicanullo@gmail.com
Facility Information:
Facility Name
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
City
Rome
State/Province
Italy/Rome
ZIP/Postal Code
00198
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD
Phone
+39 06 841 1980
Email
luigicanullo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24709541
Citation
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.
Results Reference
background
PubMed Identifier
20666787
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.
Results Reference
background
PubMed Identifier
17974109
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.
Results Reference
background
PubMed Identifier
25123761
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.
Results Reference
background
PubMed Identifier
29569763
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.
Results Reference
background
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Bioactive Surfaces vs. Conventional Surfaces in Implants Placed in Atrophic Maxilla With Simultaneous Sinus Lift
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