Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557447
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exploratory Clinical Investigation Evaluating Microbiological and Immunological Aspects of Peri-implant Crevicular Fluid and Short-term Treatment Outcomes of Two Different Implant Abutment Surfaces in Subjects Since Four to Nine Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Exploratory
Brief Summary:
A total of 22 subjects will be included in the study The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group Two peri-implant crevicular fluid PICF samples will be collected for immunological testing and two plaques samples will be collected for microbiological testing from all the enrolled subjects one from the controltest implant site and one from the contralateral toothimplant site 3 weeks after the first sampling PICF and plaques sampling will be repeated the same way
Detailed Description:
The main objective of the study is to evaluate the clinical microbiological and immunological biomarkers of implant sites which were treated with two different implant-abutment-systems anodized surface and machined surface This single-center exploratory study includes 22 subjects divided into two distinct groups Test group and Control group All subjects in both groups have undergone treatment In the Test group subjects were treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment while in the Control group treatment occurred in 2017 with NobelActive TiUnite implant and On1 machined abutment All subjects were treated by the same clinician Dr Giacomo Fabbri and were participants in two approved clinical study protocols T-190 and IIT 2017-1538 approaved by local Ethics Committee T-190 a multicenter study involved 21 subjects from Dr Fabbris center with 12 subjects available for recall Control group in this study The IIT 2017-1538 study included 61 subjects with 12 subjects scheduled for recall Test group in the current study Two subjects were part of both the studies received both the implant abutment solutions and belong to both the groups The subjects are enrolled provided they meet all the inclusion and none of the exclusion criteria and sign the informed consent Peri-implant crevicular fluid PICF and plaques samples will be collected from control and test implant sites and respective contralateral toothimplants of each participating subject for immunological and microbiological testing at two time points with an interval of approximately 3 weeks between the two sample collections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None