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

  • STATUS
    Recruiting
  • participants needed
    58
  • sponsor
    Giacomo Fabbri
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Updated on 19 February 2024
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Summary

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

Details
Condition to Study Soft Tissue Health and Stability
Age 18years - 100years
Treatment NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components
Clinical Study IdentifierNCT04383834
SponsorGiacomo Fabbri
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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