Azento IIS 3 Year Outcomes Implant Study

Tooth Loss Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this research study is to compare and evaluate the implant-body stability, survival rate, bone level changes and the implant's soft-tissue outcomes over a three year follow-up around AstraTech Implant System (ATIS) Evolution (EV) implants placed and immediately temporized with an artificial prosthetic tooth in ridges that have healed following ARP-SG for different time intervals.intervals.

Patients participating in this study are expected to return to the University of Iowa College of Dentistry for a total of 9 visits. The estimated study length per subject will vary between 42 to 48 months depending on group allocation.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tooth Loss

• NCT number: NCT04255342
• Study type: Interventional
• Source: University of Iowa
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 29, 2020
• Completion date: December 31, 2025