Clinical trial NCT04255342: Azento IIS 3 Year Outcomes Implant Study
Official title: Clinical, Radiographic, and Histomorphometric Analysis of AstraTech Implant EV Placed and Immediately Provisionalized Into Preserved Alveolar Ridges: A Prospective 3-Year Outcomes Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tooth Loss
Keywords: alveolar bone
alveolar ridge
bone grafting
bone resorption
dental implant
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
timeFrame: 1 year after permanent final crown placement
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Christopher Barwacz, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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