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

NCT05223387 | Active Not Recruiting

• 1 other identifier: C1902
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

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.

Conditions

Dental Implants; Edentulous

Keywords

Anthogyr; dental; implant

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Level Change

  Change in crestal bone level measured by analysis of standardized peri-apical xrays \[mm\].

  6 months,12 months, and 3 years after loading

Secondary Outcomes (3)

• Implant survival

  6 months,12 months, and 3 years after loading

• Prosthesis Survival

  6 months,12 months, and 3 years after prosthesis placement

• 14 item Oral Health Impact Profile (OHIP-14)

  screening visit, 6, 12 months and 3 years after loading

Other Outcomes (2)

• Adverse Events

  3 years after inclusion

• Device Deficiencies

  3 years after inclusion

Study Arms (2)

Study Group

EXPERIMENTAL

Anthogyr Axiom TL REG and corresponding Multi-Unit abutments

Device: Axiom TL REG

Control Group

ACTIVE COMPARATOR

Anthogyr Axiom BL REG and corresponding Multi-Unit abutment

Device: Axiom BL REG

Interventions

Axiom TL REG 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

Also known as: Multi-Unit abutment

Study Group

Axiom BL REG 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

Also known as: Multi-Unit abutment

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthogyr: lead

Study Sites (3)

Faculdade de Medicina Dentária da Universidade do Porto

Porto, Portugal

Location

Universidad International de Catalunya

Barcelona, Spain

Location

Universidad de Santiago de Compostela

Santiago de Compostela, Spain

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Juan Blanco Carrión, Pr.Dr.

  Universidad de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 4, 2022
• Study Start: March 30, 2022
• Primary Completion: July 18, 2025
• Study Completion (Estimated): July 18, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); PT (1)