Status:
UNKNOWN
A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________
Lead Sponsor:
Giacomo Fabbri
Conditions:
to Study Soft Tissue Health and Stability
Eligibility:
All Genders
18+ years
Brief Summary
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
Eligibility Criteria
Inclusion
- .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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04383834
Start Date
April 1 2019
End Date
May 1 2023
Last Update
May 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Studio Ban Mancini Fabbri
Cattolica, Rimini, Italy, 47841