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

NCT05500911 | Completed DMC

• 1 other identifier: ABT2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 ).

Conditions

Edentulous; Alveolar Process, Atrophy; Edentulous Alveolar Ridge Atrophy

Keywords

dental implant; implant surface; sinus lift; sinus floor elevation

Outcome Measures

Primary Outcomes (6)

• Marginal bone change

  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 change

  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 Outcomes (2)

• Apical Bone regeneration

  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.

  12 months after implant placement

Study Arms (2)

NINA- MultiNeO NH

ACTIVE COMPARATOR

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; Procedure: implant placement

MultiNeO CS

ACTIVE COMPARATOR

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; Procedure: implant placement

Interventions

sinus lift 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.

Also known as: sinus floor elevation

MultiNeO CS; NINA- MultiNeO NH

implant placement PROCEDURE

Implant will be placed in edentulous area

MultiNeO CS; NINA- MultiNeO NH

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• edentulous posterior maxillae
• residual bone height \> 4mm
• healthy periodontal conditions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo: lead

Study Sites (1)

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

Rome, Italy/Rome, 00198, Italy

Location

Related Publications (5)

• 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.

  PMID: 24709541 BACKGROUND

• 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.

  PMID: 20666787 BACKGROUND

• 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.

  PMID: 17974109 BACKGROUND

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

  PMID: 25123761 BACKGROUND

• 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.

  PMID: 29569763 BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous; Atrophy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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)

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 15, 2022
• Study Start: April 22, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 10, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)