Axiom TL REG: Anthogyr AXIOM TL Reg will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional.
In each case, the MU abutment will be placed immediately after implant placement.
Multi-Unit abutments are used to fix the prosthesis
Axiom BL REG: Axiom BL Reg implants will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional.
In each case, the MU abutment will be placed immediately after implant placement.
Multi-Unit abutments are used to fix the prosthesis
Study summary
Anthogyr Axiom Tissue-Level implants and corresponding Multi-Unit abutments recently enriched the available product range for dental surgeons. This Post-Market Clinical Follow-Up study aims at confirming the safety and performance of these products. The comparison with similar Anthogyr Axiom Bone-level implants will provide additional information on the effect of platform-switching in bone level maintenance for single and two-piece design at the implant level.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.
* Patients must be males or females who are a minimum of 18 years of age.
* Patients with a minimum of 4 weeks history of edentulism in the study area, in need of a multiple teeth replacement with dental implants
* Patients with complete soft tissue coverage of the socket at implant placement
Exclusion Criteria:
\- Patients with inadequate bone volume and/or quality: Only minor and simultaneous bone augmentation procedures will be allowed where required for regeneration of minor defects. Insufficient bone volume and quality is defined as secondary exclusion criterion and the patient will be considered as screening failure.
* Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
* Any contraindications for oral surgical procedures
* History of local irradiation therapy in the head / neck area
* Patients who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day), or have ≥ 20 pack years who use chewing tobacco
* Medical conditions requiring chronic high dose steroid therapy or high dose anti-resorptive treatment
* Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
* Cognitive impairment that would interfere with the ability to perform adequate oral hygiene (assessed by Ottawa 3DY scale)
* Patients with chronic pain
Primary outcome measure(s)
Marginal Bone Level Change — 6 months,12 months, and 3 years after loading Change in crestal bone level measured by analysis of standardized peri-apical xrays \[mm\].
Trial sites (3)
Facility
City
Region
Status
Faculdade de Medicina Dentária da Universidade do Porto
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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