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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2029-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Evaluation of NobelProcera Implant Bar Overdenture

NCT01720420

Edentulous

UNKNOWN NA

NobelZygoma TiUltra Implant System Study

NCT07258940

Edentulous Maxilla Maxillary Bone Loss Atrophic Maxilla

NOT_YET_RECRUITING NA

Study Assessing the Safety and Effectiveness of the Nobel Biocare N1 Concept System.

NCT04736771

Dental Implant

COMPLETED

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

NCT04383834

to Study Soft Tissue Health and Stability

UNKNOWN

Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

NCT00901017

Jaw, Edentulous Jaw, Edentulous, Partially

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 secondary objectives of this clinical investigation are:

* To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
* To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
* To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
* To evaluate soft tissue outcome (as measured by bleeding index, plaque index and gingival index) to 5 years from definitive prosthetic placement.
* To evaluate SADE, USADE, ADE and DD from implant insertion until 5 years follow-up visit.

Study design: 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 study devices are divided into four groups:

* Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)
* Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)
* Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)
* Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)

Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. 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 . Possible dropouts and withdrawals, as well as possible serious adverse (device) events, will be carefully monitored during the entire study period

Sequence of treatment: As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study. Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject. Standard of care follow-up visits should be scheduled as close as possible to 1-, 3- and 5- years after definitive prosthetic placement, to ascertain a homogenous data set. Deidentified periapical radiographs from each subject visit shall be uploaded to the study eCRF. All images will be forwarded to the core lab for independent analysis. As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study.

Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject.

Study duration: Once the subject has provided written informed consent and fulfilled all inclusion and none of the exclusion criteria, he/she is considered enrolled. Subject enrolment period is expected to take 7 months from time of initiation at each site. Enrolment in each group will stop once the total group size of 250 subjects has been met. The clinical investigation will continue until each subject has been followed for 5-years after final prosthetic delivery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Marginal Bone Level Change

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)

Subjects will be enrolled into Group 1 and treated with NobelActive TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic.