Azento IIS 3 Year Outcomes Implant Study

Not Applicable

Terminated

Conditions: Tooth Loss

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

Registration Number: NCT04255342

Lead Sponsor: Christopher Barwacz

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.

Detailed Description: Group 1: 3 months after ARP-SG, a dental implant will be placed using Azento® with an 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.

Group 2: 6 months after ARP-SG, a dental implant will be placed using Azento® with an AstraTech Implant System EV and an immediate temporary crown using Azento®. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.

Group 3: 9 months after ARP-SG, a dental implant will be placed using Azento® with an AstraTech Implant System EV and an immediate temporary crown using Azento®. After 3 months with the temporary crown, a definitive all-ceramic crown, made using a digital workflow will be placed.

SCREENING - Visit 1 After reading and signing the informed consent form, participants will complete a detailed medical and dental history form. The investigators will review the form with the participant to ensure they can safely participate in the study. Participants will also have an oral exam to determine if the participant qualifies for the study

VISIT 2: Abutment \& Crown Placement Group 1 (TE + 14 weeks) Group 2 (TE + 26 weeks) Group 3 (TE + 38 weeks)

Intra-oral photographs of the sites of interest will be obtained. Participants may or may not have had their implant and bone core biopsy completed as part of their participation in IRB 201806050, Clinical, radiographic and histomorphotmetric analysis of healing dynamics in human extraction sockets grafted with Bio-Oss Collagen®: A prospective 3-year post-loading study or the participants routine clinical care. At the same visit when the implant is surgically installed, the investigators will then place a prosthetic abutment and temporary crown. Participants will also receive home care instructions before they leave. This visit will last about between 1.5 to 2 hours.

VISIT 3, 4, 5: Postop (2, 6, 12 week follow-ups after implant placement) Participants will return to the clinic at 2, 6 and 12 weeks which is standard of care in many cases for implant follow-up and restoration. At this time the investigators will update medical and dental histories. Photographs and intra-oral scans (multiple digital photographs) will be taken. The investigators will review any xrays on file to assess bone levels around the implant. Sutures will be removed. Participants will be asked some questions regarding their pain and level of satisfaction in addition to the healing status of their wound. The sites will be debrided (cleaned) and oral hygiene instructions will be reviewed. At visit 4 the shade of their new permanent crown will be selected. These visits will last approximately 30-60 minutes.

VISIT 6: Final Restoration Delivery (Implant Placement + 16 weeks) The investigators will update medical and dental histories. The abutment and crown will be examined. The temporary crown will be replaced with a permanent crown. Photographs and intra-oral scans (multiple digital photographs) will be taken. The participant will be asked some questions regarding pain and level of satisfaction in addition to the healing status of their wound. This visit will last approximately 60-90 minutes.

VISIT 7, 8 \& 9: Implant Follow-ups #1, 2 \& 3 (1, 2 \& 3 years after delivery of final restoration) The participant will return to the clinic at 1, 2 and 3 years after delivery of the final restoration which is standard of care in many cases for implant restoration. At these times the investigators will update medical and dental histories . Photographs and intra-oral scans (multiple digital photographs) will be taken. An oral exam will be completed. Plaque will be removed if necessary, and oral hygiene instructions will be reviewed. Clinical measurements will be recorded. The investigators will review any xrays on file to assess bone levels around the implant. These visits will last approximately 60 minutes. Visit 9 will be the last visit.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures