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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04255342
• Other study ID #: 201911024
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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
• dental history
dental history updated to medical record

Procedure:
• suture removal
sutures will be removed
• 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).
• 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
• 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
• 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
• Bleeding on probing
bleeding on probing will be recorded
• recession
recession respective to the incisal/occlusal plane
• keratinized mucosa height
keratinized mucosa height
• plaque index
plaque index
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Christopher Barwacz

Country where clinical trial is conducted

United States, 

References & Publications (33)

Alkan EA, Parlar A, Yildirim B, Senguven B. Histological comparison of healing following tooth extraction with ridge preservation using enamel matrix derivatives versus Bio-Oss Collagen: a pilot study. Int J Oral Maxillofac Surg. 2013 Dec;42(12):1522-8. doi: 10.1016/j.ijom.2013.06.002. Epub 2013 Jul 8. — View Citation

Araujo M, Linder E, Wennstrom J, Lindhe J. The influence of Bio-Oss Collagen on healing of an extraction socket: an experimental study in the dog. Int J Periodontics Restorative Dent. 2008 Apr;28(2):123-35. — View Citation

Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12. — View Citation

Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x. — View Citation

Arora H, Khzam N, Roberts D, Bruce WL, Ivanovski S. Immediate implant placement and restoration in the anterior maxilla: Tissue dimensional changes after 2-5 year follow up. Clin Implant Dent Relat Res. 2017 Aug;19(4):694-702. doi: 10.1111/cid.12487. Epub 2017 Apr 21. — View Citation

Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. — View Citation

Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628. — View Citation

Barwacz CA, Pantzlaff E, Allareddy V, Avila-Ortiz G. Graduate Periodontics Programs' Integration of Implant Provisionalization in Core Curricula: Implementation of CODA Standard 4-10.2.d. J Dent Educ. 2017 Jun;81(6):696-706. doi: 10.21815/JDE.016.033. — View Citation

Barwacz CA, Stanford CM, Diehl UA, Cooper LF, Feine J, McGuire M, Scheyer ET. Pink Esthetic Score Outcomes Around Three Implant-Abutment Configurations: 3-Year Results. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):1126-1135. doi: 10.11607/jomi.6659. — View Citation

Barwacz, C. & Hernandez, M. (2013) Maximizing Esthetics of Fixed Interim Restorations via Direct Extrinsic Characterization. Journal of Cosmetic Dentistry 29, 122-131.

Cooper LF, Reside G, Stanford C, Barwacz C, Feine J, Nader SA, Scheyer T, McGuire M. Three-Year Prospective Randomized Comparative Assessment of Anterior Maxillary Single Implants with Different Abutment Interfaces. Int J Oral Maxillofac Implants. 2019 Jan/Feb;34(1):150-158. doi: 10.11607/jomi.6810. — View Citation

Cooper LF, Tarnow D, Froum S, Moriarty J, De Kok IJ. Comparison of Marginal Bone Changes with Internal Conus and External Hexagon Design Implant Systems: A Prospective, Randomized Study. Int J Periodontics Restorative Dent. 2016 Sep-Oct;36(5):631-42. doi: 10.11607/prd.2433. — View Citation

Crespi R, Cappare P, Crespi G, Gastaldi G, Romanos GE, Gherlone E. Tissue Remodeling in Immediate Versus Delayed Prosthetic Restoration in Fresh Socket Implants in the Esthetic Zone: Four-Year Follow-up. Int J Periodontics Restorative Dent. 2018;38(Suppl):s97-s103. doi: 10.11607/prd.3123. Epub 2018 Mar 7. — View Citation

De Rouck T, Collys K, Wyn I, Cosyn J. Instant provisionalization of immediate single-tooth implants is essential to optimize esthetic treatment outcome. Clin Oral Implants Res. 2009 Jun;20(6):566-70. doi: 10.1111/j.1600-0501.2008.01674.x. Epub 2009 Mar 3. — View Citation

Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x. — View Citation

Heberer S, Al-Chawaf B, Hildebrand D, Nelson JJ, Nelson K. Histomorphometric analysis of extraction sockets augmented with Bio-Oss Collagen after a 6-week healing period: a prospective study. Clin Oral Implants Res. 2008 Dec;19(12):1219-25. doi: 10.1111/j.1600-0501.2008.01617.x. No abstract available. — View Citation

Heinemann F, Hasan I, Schwahn C, Bourauel C, Mundt T. Bone level change of extraction sockets with Bio-Oss collagen and implant placement: a clinical study. Ann Anat. 2012 Nov;194(6):508-12. doi: 10.1016/j.aanat.2011.11.012. Epub 2011 Dec 23. — View Citation

Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990. — View Citation

Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19. — View Citation

Kan JY, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):31-9. — View Citation

Kan JY, Rungcharassaeng K, Umezu K, Kois JC. Dimensions of peri-implant mucosa: an evaluation of maxillary anterior single implants in humans. J Periodontol. 2003 Apr;74(4):557-62. doi: 10.1902/jop.2003.74.4.557. — View Citation

Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563. — View Citation

Nart J, Barallat L, Jimenez D, Mestres J, Gomez A, Carrasco MA, Violant D, Ruiz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin Oral Implants Res. 2017 Jul;28(7):840-848. doi: 10.1111/clr.12889. Epub 2016 Jun 22. — View Citation

Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29. — View Citation

Noelken R, Oberhansl F, Kunkel M, Wagner W. Immediately provisionalized OsseoSpeed() Profile implants inserted into extraction sockets: 3-year results. Clin Oral Implants Res. 2016 Jun;27(6):744-9. doi: 10.1111/clr.12651. Epub 2015 Aug 24. — View Citation

Ponsi J, Lahti S, Rissanen H, Oikarinen K. Change in subjective oral health after single dental implant treatment. Int J Oral Maxillofac Implants. 2011 May-Jun;26(3):571-7. — View Citation

Raes F, Cooper LF, Tarrida LG, Vandromme H, De Bruyn H. A case-control study assessing oral-health-related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets. Clin Oral Implants Res. 2012 May;23(5):602-8. doi: 10.1111/j.1600-0501.2011.02178.x. Epub 2011 Apr 19. — View Citation

Roccuzzo M, Gaudioso L, Lungo M, Dalmasso P. Surgical therapy of single peri-implantitis intrabony defects, by means of deproteinized bovine bone mineral with 10% collagen. J Clin Periodontol. 2016 Mar;43(3):311-8. doi: 10.1111/jcpe.12516. Epub 2016 Mar 9. — View Citation

Scheyer ET, Heard R, Janakievski J, Mandelaris G, Nevins ML, Pickering SR, Richardson CR, Pope B, Toback G, Velasquez D, Nagursky H. A randomized, controlled, multicentre clinical trial of post-extraction alveolar ridge preservation. J Clin Periodontol. 2016 Dec;43(12):1188-1199. doi: 10.1111/jcpe.12623. Epub 2016 Oct 21. — View Citation

Spyropoulou PE, Razzoog M, Sierraalta M. Restoring implants in the esthetic zone after sculpting and capturing the periimplant tissues in rest position: a clinical report. J Prosthet Dent. 2009 Dec;102(6):345-7. doi: 10.1016/S0022-3913(09)60189-X. — View Citation

Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869. — View Citation

Strietzel FP, Neumann K, Hertel M. Impact of platform switching on marginal peri-implant bone-level changes. A systematic review and meta-analysis. Clin Oral Implants Res. 2015 Mar;26(3):342-58. doi: 10.1111/clr.12339. Epub 2014 Jan 20. — View Citation

Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival	did the implant survive	3 years post implant loading
Secondary	% of vital bone via histomorphotmetric evaluation of bone core biopsies at 3 months	% of vital bone	3 months
Secondary	% of vital bone via histomorphotmetric evaluation of bone core biopsies at 6 months	% of vital bone	6 months
Secondary	% of vital bone via histomorphotmetric evaluation of bone core biopsies at 9 months	% of vital bone	9 months
Secondary	Insertion torque values	resonance frequency analysis (RFA) measured by implant stability quotient (ISQ)	3 months
Secondary	Insertion torque values	resonance frequency analysis (RFA) measured by implant stability quotient (ISQ)	6 months
Secondary	Insertion torque values	resonance frequency analysis (RFA) measured by implant stability quotient (ISQ)	9 months