Azento IIS 3 Year Outcomes Implant Study

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Device: Atlantis Abutment
* Procedure: Intra-oral photographs
* Device: provisional crown (te + 12 weeks)
* Other: medical history
* Other: dental history
* Procedure: suture removal
* Procedure: intra-oral digital scan
* Diagnostic Test: wound healing index
* Other: pain
* Other: level of satisfaction
* Procedure: debridement
* Other: oral hygiene
* Other: Shade selection
* Other: photographs
* Procedure: plaque removal
* Other: probing depth
* Other: Bleeding on probing
* Other: recession
* Other: keratinized mucosa height
* Other: plaque index
* Other: gingival index
* Device: provisional crown (te + 24 weeks)
* Device: provisional crown (te + 36 weeks)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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 | Device: Atlantis Abutment<br>* A gold-hue titanium Atlantis abutment will be connected and secured to the implant fixture, and a provisional screwmentable PMMA crown seated to verify marginal adaptation, proximal contact intensity, and occlusion. Upon any necessary modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>Procedure: Intra-oral photographs<br>* Intra-oral photographs of the sites of interest will be obtained<br>Device: provisional crown (te + 12 weeks)<br>* modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>Other: medical history<br>* medical history updated to medical record<br>Other: dental history<br>* dental history updated to medical record<br>Procedure: suture removal<br>* sutures will be removed<br>Procedure: intra-oral digital scan<br>* An intra-oral digital scan of the arch will be obtained using an intra-oral scanner<br>Diagnostic Test: wound healing index<br>* Visual assessment of the healing status will be made using a wound healing index (WHI)<br>Other: pain<br>* Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).<br>Other: level of satisfaction<br>* Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).<br>Procedure: debridement<br>* wound will be debrided<br>Other: oral hygiene<br>* oral hygiene instructions will be given<br>Other: Shade selection<br>* definitive shade selection will occur at this appointment, and a final monolithic screwmentable all-ceramic zirconium-oxide crown will be fabricated from the original Atlantis CoreFile<br>Other: photographs<br>* Intra-oral photographs will be obtained using a dSLR camera<br>Procedure: plaque removal<br>* removal of plaque on crown and surrounding teeth<br>Other: probing depth<br>* probing depths will be measured<br>Other: Bleeding on probing<br>* bleeding on probing will be recorded<br>Other: recession<br>* recession respective to the incisal/occlusal plane<br>Other: keratinized mucosa height<br>* keratinized mucosa height<br>Other: plaque index<br>* plaque index<br>Other: gingival index<br>* gingival index<br>|
| Active Comparator: Group 2<br>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. | Device: Atlantis Abutment<br>* A gold-hue titanium Atlantis abutment will be connected and secured to the implant fixture, and a provisional screwmentable PMMA crown seated to verify marginal adaptation, proximal contact intensity, and occlusion. Upon any necessary modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>Procedure: Intra-oral photographs<br>* Intra-oral photographs of the sites of interest will be obtained<br>Device: provisional crown (te + 12 weeks)<br>* modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>Other: medical history<br>* medical history updated to medical record<br>Other: dental history<br>* dental history updated to medical record<br>Procedure: suture removal<br>* sutures will be removed<br>Procedure: intra-oral digital scan<br>* An intra-oral digital scan of the arch will be obtained using an intra-oral scanner<br>Diagnostic Test: wound healing index<br>* Visual assessment of the healing status will be made using a wound healing index (WHI)<br>Other: pain<br>* Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).<br>Other: level of satisfaction<br>* Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).<br>Procedure: debridement<br>* wound will be debrided<br>Other: oral hygiene<br>* oral hygiene instructions will be given<br>Other: Shade selection<br>* definitive shade selection will occur at this appointment, and a final monolithic screwmentable all-ceramic zirconium-oxide crown will be fabricated from the original Atlantis CoreFile<br>Other: photographs<br>* Intra-oral photographs will be obtained using a dSLR camera<br>Procedure: plaque removal<br>* removal of plaque on crown and surrounding teeth<br>Other: probing depth<br>* probing depths will be measured<br>Other: Bleeding on probing<br>* bleeding on probing will be recorded<br>Other: recession<br>* recession respective to the incisal/occlusal plane<br>Other: keratinized mucosa height<br>* keratinized mucosa height<br>Other: plaque index<br>* plaque index<br>Other: gingival index<br>* gingival index<br>Device: provisional crown (te + 24 weeks)<br>* modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>|
| Active Comparator: Group 3<br>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 | Device: Atlantis Abutment<br>* A gold-hue titanium Atlantis abutment will be connected and secured to the implant fixture, and a provisional screwmentable PMMA crown seated to verify marginal adaptation, proximal contact intensity, and occlusion. Upon any necessary modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>Procedure: Intra-oral photographs<br>* Intra-oral photographs of the sites of interest will be obtained<br>Device: provisional crown (te + 12 weeks)<br>* modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>Other: medical history<br>* medical history updated to medical record<br>Other: dental history<br>* dental history updated to medical record<br>Procedure: suture removal<br>* sutures will be removed<br>Procedure: intra-oral digital scan<br>* An intra-oral digital scan of the arch will be obtained using an intra-oral scanner<br>Diagnostic Test: wound healing index<br>* Visual assessment of the healing status will be made using a wound healing index (WHI)<br>Other: pain<br>* Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).<br>Other: level of satisfaction<br>* Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).<br>Procedure: debridement<br>* wound will be debrided<br>Other: oral hygiene<br>* oral hygiene instructions will be given<br>Other: Shade selection<br>* definitive shade selection will occur at this appointment, and a final monolithic screwmentable all-ceramic zirconium-oxide crown will be fabricated from the original Atlantis CoreFile<br>Other: photographs<br>* Intra-oral photographs will be obtained using a dSLR camera<br>Procedure: plaque removal<br>* removal of plaque on crown and surrounding teeth<br>Other: probing depth<br>* probing depths will be measured<br>Other: Bleeding on probing<br>* bleeding on probing will be recorded<br>Other: recession<br>* recession respective to the incisal/occlusal plane<br>Other: keratinized mucosa height<br>* keratinized mucosa height<br>Other: plaque index<br>* plaque index<br>Other: gingival index<br>* gingival index<br>Device: provisional crown (te + 36 weeks)<br>* modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | did the implant survive | 3 years post implant loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of vital bone via histomorphotmetric evaluation of bone core biopsies at 3 months | % of vital bone | 3 months | 
| % of vital bone via histomorphotmetric evaluation of bone core biopsies at 6 months | % of vital bone | 6 months | 
| % of vital bone via histomorphotmetric evaluation of bone core biopsies at 9 months | % of vital bone | 9 months | 
| Insertion torque values | resonance frequency analysis (RFA) measured by implant stability quotient (ISQ) | 3 months | 
| Insertion torque values | resonance frequency analysis (RFA) measured by implant stability quotient (ISQ) | 6 months | 
| Insertion torque values | resonance frequency analysis (RFA) measured by implant stability quotient (ISQ) | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alveolar bone, alveolar ridge, bone grafting, bone resorption, dental implant