Evaluation of Implant-prosthetic Rehabilitation Performed With Two Implants With Different Surface Characteristics

NCT05495867 | Completed DMC

• 1 other identifier: ABT1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this case-control study a bioactive implant surface was compared with traditional surfaced implants. Primary objectives: Test the implant stability in post-extractive sites, comparing traditional surfaced implants (MultiNeO CS, control group) to bioactive surfaced implants (NINA- MultiNeO NH, treatment group). Primary outcome endpoints were Implant stability, assessed through Implant stability quotient (ISQ) values and Marginal bone loss (MBL)

Conditions

Missing Teeth; Edentulous Jaw; Edentulous Mouth

Keywords

dental implant; bioactivation; implant surface

Outcome Measures

Primary Outcomes (5)

• Marginal bone loss

  Radiographic evaluation of the marignal 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 marignal 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)

  immediately after implant placement

• Implant stability

  check implant stability using resonant frequency analysis (RFA)

  30 days after implant placement

• Implant stability

  check implant stability using resonant frequency analysis (RFA)

  45 days after implant placement

Secondary Outcomes (1)

• insertion torque curve

  During implant placement (T0 baseline)

Study Arms (2)

NINA- MultiNeO NH

EXPERIMENTAL

implant with bioactive surface

Procedure: implant placement

MultiNeO CS

ACTIVE COMPARATOR

implant with traditional surface

Procedure: implant placement

Interventions

implant placement PROCEDURE

implant placement in edentulous area

MultiNeO CS; NINA- MultiNeO NH

Eligibility Criteria

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

You may qualify if:

• Patient with type 1-2 post extraction sites
• Subject is 30-80 years old
• Patient ASA 1 or 2
• Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
• Patients that are willing to sign an informed consent and participate in a clinical study

You may not qualify if:

• Absence Type 1-2 post extraction sites
• Patient ASA 3 or 4
• Untreated Periodontitis
• Any sites where an implant already failed sites
• Allergy declared to one or more medicaments to be used during treatment
• Pregnancy (confirmed by verbal inquiry)

Sponsors & Collaborators

• Luigi Canullo: lead

Study Sites (1)

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

Rome, Italy/Rome, 00198, Italy

Location

Related Publications (3)

• Wennerberg A, Albrektsson T. Effects of titanium surface topography on bone integration: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:172-84. doi: 10.1111/j.1600-0501.2009.01775.x.

  PMID: 19663964 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

• Gianfreda F, Antonacci D, Raffone C, Muzzi M, Pistilli V, Bollero P. Microscopic Characterization of Bioactivate Implant Surfaces: Increasing Wettability Using Salts and Dry Technology. Materials (Basel). 2021 May 17;14(10):2608. doi: 10.3390/ma14102608.

  PMID: 34067747 BACKGROUND

MeSH Terms

Conditions

Anodontia; Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Mouth Diseases

Study Officials

• Luigi Canullo, DDS PhD

  Studio odontoiatrico associato Cicchese Canullo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: April 22, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: the data will be available for the duration of the study
• Access Criteria: the data will be available for the duration of the study

Locations

IT (1)