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

NCT ID: NCT05223387

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2027-07-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

Anthogyr Axiom TL REG and corresponding Multi-Unit abutments

Group Type: EXPERIMENTAL

Axiom TL REG

Intervention Type: DEVICE

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

Control Group

Anthogyr Axiom BL REG and corresponding Multi-Unit abutment

Group Type: ACTIVE_COMPARATOR

Axiom BL REG

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Multi-Unit abutment; Multi-Unit abutment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anthogyr

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Blanco Carrión, Pr.Dr.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Santiago de Compostela

Locations

Faculdade de Medicina Dentária da Universidade do Porto

Porto, , Portugal

Universidad International de Catalunya

Barcelona, , Spain

Universidad de Santiago de Compostela

Santiago de Compostela, , Spain

Countries

Portugal; Spain

Other Identifiers

C1902

Identifier Type: -

Identifier Source: org_study_id