Azento IIS 3 Year Outcomes Implant Study

Christopher Barwacz

Status

Terminated

Conditions

Tooth Loss

Treatments

Device: Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery

Study type

Interventional

Funder types

Other

Identifiers

NCT04255342

201911024

Details and patient eligibility

About

The revised purpose of this study is to compare and evaluate the stability of the implant body, survival rate, bone-level changes, and the implant's soft-tissue outcomes over a period of 1 year. Only 1 tooth is studied per participant.

In July of 2024, the revised protocol and revised Statistical Analysis plan were amended post-hoc, and the revised protocol and statistical analysis plan were approved by the IRB review committee in July of 2024.

As a result, the study has been terminated due to a change in the study's data analysis, and so the study will only analyze data up to and including the 1-year point.

Enrollment

25 patients

Sex

All

Ages

18 to 95 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects may identify as either male, female, or intersex
Age: 18 years or older
Subjects with a healed, single-rooted tooth (except mandibular incisors) that has previously undergone ARP-SG with particulate allograft material within the past 2 months.
Subjects must have stable occlusion, with absence of caries or other known acute pathology (i.e., untreated endodontic lesion, periodontal abscess, external/internal resorption, etc.) on teeth proximal to the implant site that would negatively influence implant outcomes
Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
Subjects must have read, understood and signed an informed consent form
Subjects must be willing to return for the required number of visits
Subjects' tooth must be a permanent tooth, not a primary tooth (also known as baby tooth).

Exclusion criteria

Mandibular incisors
Acute infection associated with the tooth to be extracted or with adjacent teeth
Unstable occlusion, presence of caries or other acute pathology on teeth adjacent to the implant site
History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day]), history of head/neck radiation, history of chemotherapy within the last 5 years
Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
Pregnant women or nursing mothers
Subjects that are unwilling or unable to sign the informed consent
History of lack of compliance with dental visits
Subjects unwilling to return for the required number of visits
Subject currently undergoing orthodontic treatment