Clinical trial NCT05223387: Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial
Official title: Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implants
Edentulous
Keywords: Anthogyr
dental
implant
Lead sponsor: Anthogyr
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Marginal Bone Level Change
timeFrame: 6 months,12 months, and 3 years after loading
Secondary outcomes:
measure: Implant survival
timeFrame: 6 months,12 months, and 3 years after loading
measure: Prosthesis Survival
timeFrame: 6 months,12 months, and 3 years after prosthesis placement
measure: 14 item Oral Health Impact Profile (OHIP-14)
timeFrame: screening visit, 6, 12 months and 3 years after loading
Other outcomes:
measure: Adverse Events
timeFrame: 3 years after inclusion
measure: Device Deficiencies
timeFrame: 3 years after inclusion
Locations:
city: Porto
country: Portugal
facility: Faculdade de Medicina Dentária da Universidade do Porto
city: Barcelona
country: Spain
facility: Universidad International de Catalunya
city: Santiago De Compostela
country: Spain
facility: Universidad de Santiago de Compostela
Study officials:
affiliation: Universidad de Santiago de Compostela
name: Juan Blanco Carrión, Pr.Dr.
role: PRINCIPAL_INVESTIGATOR
References: