Active — Not RecruitingNot Applicable

A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components

United States1,000 participantsStarted 2021-05-26

Plain-language 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) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 cli…

What they're measuring

Marginal bone level change

Timeframe: Definitive prosthetic delivery to 5-years follow-up

Trial details

NCT IDNCT04737421

SponsorNobel Biocare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-05-31