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Azento IIS 3 Year Outcomes Implant Study

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ClinicalTrials.gov Identifier: NCT04255342
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher Barwacz, University of Iowa

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.


Condition or disease Intervention/treatment Phase
Tooth Loss 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors collecting the data and conducting the appropriate statistical analyses for all outcomes in the study will be blinded
Primary Purpose: Treatment
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
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Active Comparator: Group 1
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
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.

Procedure: Intra-oral photographs
Intra-oral photographs of the sites of interest will be obtained

Device: provisional crown (te + 12 weeks)
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.

Other: medical history
medical history updated to medical record

Other: dental history
dental history updated to medical record

Procedure: suture removal
sutures will be removed

Procedure: intra-oral digital scan
An intra-oral digital scan of the arch will be obtained using an intra-oral scanner

Diagnostic Test: wound healing index
Visual assessment of the healing status will be made using a wound healing index (WHI)

Other: pain
Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).

Other: level of satisfaction
Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).

Procedure: debridement
wound will be debrided

Other: oral hygiene
oral hygiene instructions will be given

Other: Shade selection
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

Other: photographs
Intra-oral photographs will be obtained using a dSLR camera

Procedure: plaque removal
removal of plaque on crown and surrounding teeth

Other: probing depth
probing depths will be measured

Other: Bleeding on probing
bleeding on probing will be recorded

Other: recession
recession respective to the incisal/occlusal plane

Other: keratinized mucosa height
keratinized mucosa height

Other: plaque index
plaque index

Other: gingival index
gingival index

Active Comparator: Group 2
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
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.

Procedure: Intra-oral photographs
Intra-oral photographs of the sites of interest will be obtained

Device: provisional crown (te + 12 weeks)
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.

Other: medical history
medical history updated to medical record

Other: dental history
dental history updated to medical record

Procedure: suture removal
sutures will be removed

Procedure: intra-oral digital scan
An intra-oral digital scan of the arch will be obtained using an intra-oral scanner

Diagnostic Test: wound healing index
Visual assessment of the healing status will be made using a wound healing index (WHI)

Other: pain
Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).

Other: level of satisfaction
Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).

Procedure: debridement
wound will be debrided

Other: oral hygiene
oral hygiene instructions will be given

Other: Shade selection
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

Other: photographs
Intra-oral photographs will be obtained using a dSLR camera

Procedure: plaque removal
removal of plaque on crown and surrounding teeth

Other: probing depth
probing depths will be measured

Other: Bleeding on probing
bleeding on probing will be recorded

Other: recession
recession respective to the incisal/occlusal plane

Other: keratinized mucosa height
keratinized mucosa height

Other: plaque index
plaque index

Other: gingival index
gingival index

Device: provisional crown (te + 24 weeks)
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.

Active Comparator: Group 3
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
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.

Procedure: Intra-oral photographs
Intra-oral photographs of the sites of interest will be obtained

Device: provisional crown (te + 12 weeks)
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.

Other: medical history
medical history updated to medical record

Other: dental history
dental history updated to medical record

Procedure: suture removal
sutures will be removed

Procedure: intra-oral digital scan
An intra-oral digital scan of the arch will be obtained using an intra-oral scanner

Diagnostic Test: wound healing index
Visual assessment of the healing status will be made using a wound healing index (WHI)

Other: pain
Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).

Other: level of satisfaction
Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).

Procedure: debridement
wound will be debrided

Other: oral hygiene
oral hygiene instructions will be given

Other: Shade selection
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

Other: photographs
Intra-oral photographs will be obtained using a dSLR camera

Procedure: plaque removal
removal of plaque on crown and surrounding teeth

Other: probing depth
probing depths will be measured

Other: Bleeding on probing
bleeding on probing will be recorded

Other: recession
recession respective to the incisal/occlusal plane

Other: keratinized mucosa height
keratinized mucosa height

Other: plaque index
plaque index

Other: gingival index
gingival index

Device: provisional crown (te + 36 weeks)
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.




Primary Outcome Measures :
  1. Implant survival [ Time Frame: 3 years post implant loading ]
    did the implant survive


Secondary Outcome Measures :
  1. % of vital bone via histomorphotmetric evaluation of bone core biopsies at 3 months [ Time Frame: 3 months ]
    % of vital bone

  2. % of vital bone via histomorphotmetric evaluation of bone core biopsies at 6 months [ Time Frame: 6 months ]
    % of vital bone

  3. % of vital bone via histomorphotmetric evaluation of bone core biopsies at 9 months [ Time Frame: 9 months ]
    % of vital bone

  4. Insertion torque values [ Time Frame: 3 months ]
    resonance frequency analysis (RFA) measured by implant stability quotient (ISQ)

  5. Insertion torque values [ Time Frame: 6 months ]
    resonance frequency analysis (RFA) measured by implant stability quotient (ISQ)

  6. Insertion torque values [ Time Frame: 9 months ]
    resonance frequency analysis (RFA) measured by implant stability quotient (ISQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255342


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Christopher Barwacz
Investigators
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Principal Investigator: Christopher Barwacz, DDS University of Iowa
Publications:
Barwacz, C. & Hernandez, M. (2013) Maximizing Esthetics of Fixed Interim Restorations via Direct Extrinsic Characterization. Journal of Cosmetic Dentistry 29, 122-131.

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Responsible Party: Christopher Barwacz, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT04255342    
Other Study ID Numbers: 201911024
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Christopher Barwacz, University of Iowa:
alveolar bone
alveolar ridge
bone grafting
bone resorption
dental implant
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases