Clinical trial NCT04737421: A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
Official title: A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Marginal Bone Level Change
Keywords: bone remodelling
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.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.

If the subject wishes to withdraw from the clinical study, he/she may do so at any time and for any reason during the clinical study. If provided, the reason for withdrawal should be recorded and documented in the subject's medical record and in the eCRF.

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) 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

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 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.

Eligibility criteria: 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 clinic

Primary outcomes:
measure: Marginal bone level change
timeFrame: Definitive prosthetic delivery to 5-years follow-up
Secondary outcomes:
measure: Marginal bone level change
timeFrame: Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
measure: Cumulative Survival rate/Cumulative success rate
timeFrame: Definitive prosthetic delivery to 5-year follow-up
measure: Prsothetic suviival and success rate
timeFrame: Definitive prosthetic delivery to 5-years follow-up
measure: Sost tissue outcome- Bleeding index
timeFrame: Definitive prosthetic delivery to 5-years follow-up
measure: Sost tissue outcome- Plaque index
timeFrame: Definitive prosthetic delivery to 5-years follow-up
measure: Sost tissue outcome- Ginigval index
timeFrame: Definitive prosthetic delivery to 5-years follow-up
measure: Adverse event
timeFrame: Implant insertion to 5-years follow-up
Other outcomes:
Locations:
city: Madison
country: United States
facility: Madison Prosthodontics
state: Alabama
city: Arlington Heights
country: United States
facility: Northwest Oral and Maxillofacial Surgery
state: Illinois
city: Saint Charles
country: United States
facility: Midwest Dental Implantology
state: Illinois
city: New York
country: United States
facility: New York Center for Orthognathic and Maxillofacial Surgery
state: New York
city: Tualatin
country: United States
facility: Periodontal Associates
state: Oregon
city: Pyrmont
country: Australia
facility: Dentartisans Pty ltd
state: New South Wales
city: West Perth
country: Australia
facility: Bc Prosthodontics
state: Perth
city: Melbourne
country: Australia
facility: Melbourne Dental School The University of Melbourne
city: Vienna
country: Austria
facility: Implantologie und Ästhetische Zahnheilkunde
city: Wien
country: Austria
facility: Akademie für orale Implantologie GmbH & Co
city: Herning
country: Denmark
facility: Herning Implantat Center
city: Tampere
country: Finland
facility: Dental Center Helmiäinen
city: Lyon
country: France
facility: Cabinet du Dr Noharet
city: Montpellier
country: France
facility: BGLP
city: Paris
country: France
facility: IFCIA
city: Karlstadt
country: Germany
facility: DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik
city: Cattolica
country: Italy
facility: Studio Odontoiatrico Specialistico Ban Mancini Fabbri
city: Verona
country: Italy
facility: UOC di Chirurgia Maxillo-Facciale e Odontoiatria
city: Breda
country: Netherlands
facility: ParoBrea- Parodontologie & Implantologie
city: Groningen
country: Netherlands
facility: Department of Oral and Maxillofacial Surgery University Medical Center Groningen
city: Hertogenbosch
country: Netherlands
facility: Staas & Bergmans Zorgvooruwmond B.V.
city: Harstad
country: Norway
facility: The Oris Dental Harstad
city: Lisbon
country: Portugal
facility: Maló Clinic
city: Barcelona
country: Spain
facility: Clinica Lluch
city: Málaga
country: Spain
facility: Clinica Dental Crooke & Laguna
city: Palma De Mallorca
country: Spain
facility: Altés & Mesquida
city: Göteborg
country: Sweden
facility: Folktandvården Västra Götaland, Brånemarkkliniken
city: Malmö
country: Sweden
facility: Pequrio AB
city: Egerkingen
country: Switzerland
facility: Dentalspecialist
city: Luzern
country: Switzerland
facility: Brunner Praxis für Zahnmedizin
city: Oberrieden
country: Switzerland
facility: Centrella Zahnärzte
city: Rorschach
country: Switzerland
facility: Bodensee-Implantat-Zentrum AG
Study officials:
References: