NCT05223387

Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Anthogyr · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a multicenter, comparative, prospective, randomized, controlled, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 3 years. Anthogyr Axiom TL and BL REG and corresponding Multi-Unit abutments 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 total 8 visits per patient are scheduled in this study Implant and prosthesis survival, success, bone level changes, patient reported outcome, soft tissue assessment and adverse events (AEs) will be assessed. The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product. 3 centers will participate in Spain and Portugal. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.

Conditions

• Dental Implants
• Edentulous

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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

Timeline

• Start date: 2022-03-30
• Primary completion: 2025-07-18
• Completion: 2027-07-18
• First posted: 2022-02-04
• Last updated: 2025-03-19

Locations

3 sites across 2 countries: Portugal, Spain