A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________

2017-1538: A 3-years Investigator Initiated Study to Evaluate the Soft Tissue Health and Stability in the Mandible and/or Maxilla Using the NobelActive® TiUltra™ and On1™ Base/Xeal™

Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes

Study Overview

• Status: Recruiting
• Conditions: to Study Soft Tissue Health and Stability
• Intervention / Treatment: Device: NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components

• Study Type: Observational
• Enrollment (Anticipated): 58

Contacts and Locations

• Study Contact: Name: Giacomo Fabbri, Dentist; Phone Number: 0039541963434; Email: info@bmf.dental
• Study Contact Backup: Name: emanuela fontanarosa; Phone Number: 0039541963434; Email: info@bmf.dental

Study Locations

• Italy
  • Rimini
    • Cattolica, Rimini, Italy, 47841
      • Recruiting
      • Studio Ban Mancini Fabbri
      • Contact: Giacomo Fabbri, Dentista; Phone Number: 3473167583; Email: info@bmf.dental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects, at least 18 years old, in need of one single restoration in the posterior region of the maxilla and/or the mandible.

Description

Inclusion Criteria:

.The subject inclusion criteria are listed below. The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.

Obtained informed consent from the subject. The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).

The subject shall be healthy and compliant with good oral hygiene. Full-mouth bleeding score (FMBS) lower than 25 %[10]. Full-mouth plaque score (FMPI) lower than 20% [11]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla.

The subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).

The implant sites are free from infection and extraction remnants. The subject is suitable for a 1-stage surgical procedure. Sufficient amount of buccal and lingual keratinized mucosa. The healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems.

The subject has a sufficient amount of bone for placing NobelActive TiUltra with a length of at least 7 mm.

The following subject inclusion criteria apply at time of surgery:

Primary implant stability as assessed by manual hand testing.

Exclusion Criteria:

• The subject is not able to give her/his informed consent of participating. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.

Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.

Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.

Infections in the planned implantation site or adjacent tissue. Acute, untreated periodontitis in the planned implantation site or adjacent tissue.

Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).

Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.

Alcohol or drug abuse as noted in subject records or in subject history. Smoking less 10 cigarettes/day. Fresh extraction sites (up to 6 weeks). Severe bruxism or other destructive habits. Pregnant or lactating women at the time of implant insertion. Previous bone augmentation (lateral and/or vertical). Soft tissue augmentation less than 2 months before implant placement. Subject has allergic or adverse reactions to the restorative material

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™	Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes	47 months (8 months enrolment + 36 months follow up + 3 months study closure)

Collaborators and Investigators

• Sponsor: Giacomo Fabbri
• Investigators: Principal Investigator: Giacomo Fabbri, Dentist, Studio Ban Mancini Fabbri

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017-1538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No