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

Primary Purpose

Dental Implants, Edentulous

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Axiom TL REG

Axiom BL REG

About this trial

This is an interventional treatment trial for Dental Implants focused on measuring Anthogyr, dental, implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculdade de Medicina Dentária da Universidade do PortoRecruiting
Universidad International de CatalunyaRecruiting
Universidad de Santiago de CompostelaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Anthogyr Axiom TL REG and corresponding Multi-Unit abutments

Anthogyr Axiom BL REG and corresponding Multi-Unit abutment

Outcomes

Primary Outcome Measures

Marginal Bone Level Change

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

Secondary Outcome Measures

Implant survival

A surviving implant is an implant that is in place at the time of evaluation.

Prosthesis Survival

a surviving prosthesis is a prosthesis that is not broken at the time of evaluation.

14 item Oral Health Impact Profile (OHIP-14)

he local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).

Full Information

NCT ID

NCT05223387

First Posted

January 21, 2022

Last Updated

July 19, 2022

Sponsor

Anthogyr

1. Study Identification

Unique Protocol Identification Number

NCT05223387

Brief Title

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

Acronym

IBERICA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2022 (Actual)

Primary Completion Date

August 20, 2024 (Anticipated)

Study Completion Date

August 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anthogyr

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Implants, Edentulous

Keywords

Anthogyr, dental, implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

Anthogyr Axiom TL REG and corresponding Multi-Unit abutments

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Anthogyr Axiom BL REG and corresponding Multi-Unit abutment

Intervention Type

Device

Intervention Name(s)

Axiom TL REG

Other Intervention Name(s)

Multi-Unit abutment

Intervention Description

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

Intervention Name(s)

Axiom BL REG

Other Intervention Name(s)

Multi-Unit abutment

Intervention Description

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

Primary Outcome Measure Information:

Title

Marginal Bone Level Change

Description

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

Time Frame

6 months,12 months, and 3 years after loading

Secondary Outcome Measure Information:

Title

Implant survival

Description

A surviving implant is an implant that is in place at the time of evaluation.

Time Frame

6 months,12 months, and 3 years after loading

Title

Prosthesis Survival

Description

a surviving prosthesis is a prosthesis that is not broken at the time of evaluation.

Time Frame

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

Title

14 item Oral Health Impact Profile (OHIP-14)

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Adverse Events

Description

Adverse Events will be recorded at every visit. Adverse Events will be recorded at every visit.

Time Frame

3 years after inclusion

Title

Device Deficiencies

Description

Adverse Events will be recorded at every visit. Any device complications and deficiencies will be recorded as Device Deficiencies.

Time Frame

3 years after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Chauvet

Phone

+33 (0)4 50 58 02 37

marie.chauvet@anthogyr.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas Courtois

Phone

+33 (0)4 50 58 02 37

nicolas.courtois@anthogyr.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Blanco Carrión, Pr.Dr.

Organizational Affiliation

Universidad de Santiago de Compostela

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculdade de Medicina Dentária da Universidade do Porto

City

Porto

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricardo Almeida, Pr-Dr

First Name & Middle Initial & Last Name & Degree

Ricardo Almeida, Pr.Dr.

Facility Name

Universidad International de Catalunya

City

Barcelona

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Nart, Pr.Dr

Facility Name

Universidad de Santiago de Compostela

City

Santiago De Compostela

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan Blanco Carrión, Pr.Dr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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