Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants

Dental Implants Clinical Trial

Official title:

A Retrospective Multicenter Study Evaluating ATLANTIS™ Abutments on Implants From Four Manufacturers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496091
• Other study ID #: C-AA-14-003
• Status: Completed
• Start date: August 31, 2015
• Est. completion date: March 30, 2018

Study information

• Verified date: April 2020
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• ATLANTIS Abutment

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham, Division of Prosthodontics	Birmingham	Alabama
United States	University of North Carolina, School of Dentistry	Chapel Hill	North Carolina
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	University of California, Los Angeles, School of Dentistry	Los Angeles	California
United States	Columbia University, College of Dental Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Success Rate	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.	Minium of 2 years and a maximum of 8 years of use.
Secondary	Study Position Implant and Abutment Survival	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.	Minium of 2 years and a maximum of 8 years of use.
Secondary	Presence of Plaque	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.	Minium of 2 years and a maximum of 8 years of use.
Secondary	Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	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.	Minium of 2 years and a maximum of 8 years of use.
Secondary	Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP	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.	Minium of 2 years and a maximum of 8 years of use.
Secondary	Marginal Bone Level Change	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.	Minium of 2 years and a maximum of 8 years of use.