Azento IIS 3 Year Outcomes Implant Study
Tooth Loss
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring alveolar bone, alveolar ridge, bone grafting, bone resorption, dental implant
Eligibility Criteria
Inclusion Criteria: patients participating in University of Iowa IRB approved study 201806050 or
- 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 anorganic bovine bone mineral graft
- 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
Exclusion Criteria:
- - 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])
- 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
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Group 1
Group 2
Group 3
Group 1: 3 months post-ARP-SG and dental implant placement using Azento® with an Astra Tech Implant® EV implant and immediate implant provisionalization using Azento®. At 3 months post-DIP&P, a definitive all-ceramic crown, fabricated using a digital workflow (CoreFile), will be placed
Group 2: at 6 months post-ARP-SG and dental implant placement using Azento® with an Astra Tech Implant® EV implant and immediate implant provisionalization using Azento®. At 3 months post-DIP&P, a definitive all-ceramic crown, fabricated using a digital workflow (CoreFile), will be placed.
Group 3: 9 months post-ARP-SG and dental implant placement using Azento® with an Astra Tech Implant® EV implant and immediate implant provisionalization using Azento®. At 3 months post-DIP&P, a definitive all-ceramic crown, fabricated using a digital workflow (CoreFile), will be placed