Status:
ACTIVE_NOT_RECRUITING
Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial
Lead Sponsor:
Anthogyr
Conditions:
Dental Implants
Edentulous
Eligibility:
All Genders
18+ years
Phase:
NA
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 confirm...
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 an...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05223387
Start Date
March 30 2022
End Date
July 18 2027
Last Update
March 19 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculdade de Medicina Dentária da Universidade do Porto
Porto, Portugal
2
Universidad International de Catalunya
Barcelona, Spain
3
Universidad de Santiago de Compostela
Santiago de Compostela, Spain