Status:
ACTIVE_NOT_RECRUITING
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
Lead Sponsor:
Nobel Biocare
Conditions:
Marginal Bone Level Change
Eligibility:
All Genders
18-65 years
Brief Summary
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) w...
Detailed Description
Primary Objective: The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit. Secondary Objective:The sec...
Eligibility Criteria
Inclusion
- Subject signed the informed consent
- Subject is between 18 and 70 years of age
- Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
- Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
- Subject with sufficient bone volume for implant placement.
- Subject is compliant with good oral hygiene as judged by the clinician.
Exclusion
- Anatomical conditions discovered during surgery preventing the use of intended implant system.
- Subjects with history of allergy or adverse reactions to any materials used
- Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)\*
- Heavy smokers (\>10 cigarettes per day)
- Severe bruxism or dysfunctional tendencies
- Previous oro-maxillo facial radiotheraphy
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
- Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- Infections in the planned implantation site or adjacent tissue.
- Documented complete remission of \>3 years if history of non-oral cancer.
- Pregnant or lactating women at the time of implant insertion. \*Assessment of A1C level is not required unless it is standard of care at the treating clinic
Key Trial Info
Start Date :
May 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04737421
Start Date
May 26 2021
End Date
May 31 2029
Last Update
May 25 2025
Active Locations (32)
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1
Madison Prosthodontics
Madison, Alabama, United States, 35758
2
Northwest Oral and Maxillofacial Surgery
Arlington Heights, Illinois, United States, 60005
3
Midwest Dental Implantology
Saint Charles, Illinois, United States, 60174
4
New York Center for Orthognathic and Maxillofacial Surgery
New York, New York, United States, 10022