Tooth Loss
Conditions
Keywords
alveolar bone, alveolar ridge, bone grafting, bone resorption, dental implant
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.
Interventions
DEVICEImplant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery
At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.
Sponsors
Christopher Barwacz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement. | 1 year after permanent final crown placement | For participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery Implant Placement and Temporary Crown using AstraTech Implant System EV, Final Crown Delivery: At least 3 months after tooth removal and bone grafting, a dental implant will be placed using Azento, a commercially-available product that uses computer technology to plan the dental implant placement using the AstraTech Implant System EV and an immediate implant temporary crown using Azento. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 10 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 Participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement.
For participants that had permanent restoration of the final crown performed, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 1 year of having the permanent final crown placement. Note: Only 1 implant was placed per participant.
Time frame: 1 year after permanent final crown placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant Placement and Temporary Crown Using AstraTech Implant System EV, Final Crown Delivery | Percentage of Participants That Had an Implant That Survived 1 Year After Permanent Final Crown Placement. | 22 Participants |