Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

Completed

• Conditions: Dental Implants

• Registration Number: NCT02496091
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief Summary

The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. The study includes retrospective data collection from the medical records and data collection from one prospective study visit with a clinical examination.The primary objective is to evaluate success. Success is defined as that the study implant and abutment are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant tissues are reported during the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Study Start: 2015-08-31
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2020-04
• Results First Submitted: 2020-04-14
• Results First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Results First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s):

  • during 2010, 2011, 2012 or 2013
  • made of titanium or gold-shaded titanium
  • connected to implants from: BIOMET 3i; Straumann; Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System).

• Being at least 18 years at day of enrollment

• Having signed and dated the informed consent form

Exclusion Criteria

• Unable to come for study visit
• Not willing to participate in the study or not able to understand the content of the study.
• Involvement in the planning and conduct of the study (applies to both DENTSPLY Implants staff and staff at the study site).
• Simultaneous participation in another clinical study that may interfere with the present study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Success Rate	Minium of 2 years and a maximum of 8 years of use.	Success defined as study position implant and abutment in situ and no Adverse Event(s) related to implant, abutment or adjacent peri-implant tissues reported during study.

Secondary Outcome Measures

Name	Time	Method
Study Position Implant and Abutment Survival	Minium of 2 years and a maximum of 8 years of use.	Survival defined as study position implant and abutment in situ during study. The presence of the study position implant and abutment in the mouth was recorded. The implant and abutment had to be the ones included in the permanent prosthetic restoration when it was delivered / installed.; Each study position was categorized as survived (No/Yes). It was categorized as survived=Yes when both had been in situ during study. It was categorized as survived=No when either the implant or abutment had been lost during study.
Presence of Plaque	Minium of 2 years and a maximum of 8 years of use.	Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.
Marginal Bone Level Change	Minium of 2 years and a maximum of 8 years of use.	Marginal bone level (MBL) determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the study follow-up visit was compared to values obtained at delivery of permanent restoration i.e. loading (baseline), or within the first 12 months after loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	Minium of 2 years and a maximum of 8 years of use.	PPD was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in whole millimetre. PPD mean values per study positon were calculated.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP	Minium of 2 years and a maximum of 8 years of use.	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). BoP was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe.; BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket. Presented as % of positions that show presence of bleeding on probing at time of the follow-up visit.

Trial Locations

Locations (6)

University of Alabama at Birmingham, Division of Prosthodontics; 🇺🇸 Birmingham, Alabama, United States

University of California, Los Angeles, School of Dentistry; 🇺🇸 Los Angeles, California, United States

Nova Southeastern University, College of Dental Medicine; 🇺🇸 Fort Lauderdale, Florida, United States

University of Iowa, College of Dentistry; 🇺🇸 Iowa City, Iowa, United States

Columbia University, College of Dental Medicine; 🇺🇸 New York, New York, United States

University of North Carolina, School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States