Viewing Study NCT04328051



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Last Modification Date: 2024-10-26 @ 1:31 PM
Study NCT ID: NCT04328051
Status: UNKNOWN
Last Update Posted: 2020-03-31
First Post: 2018-06-21

Brief Title: Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage
Sponsor: University of Barcelona
Organization: University of Barcelona

Study Overview

Official Title: Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage A Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2020-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement
Detailed Description: Location This study is going to take place in the Dentistry Hospital of the University of Barcelona Campus of Bellvitge

Study subjects The sample 105 patients consists of patients with single tooth edentulous spaces or posterior maxillary andor mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns All of them are being properly informed about the study according to the Comité Ético CEIC del Hospital Odontològic Universitat de Barcelona guidelines and informed consent must be signed prior to the interventions

Material Registration papers for the study dental implants surgery material prosthetic components Florida Probe Software Periapical x-rays computer Software Stata 14 and Software ImageJ

Determinations Clinical radiographic and microbiologic measures since implant placement prosthesis placement and 3 6 9 and 12 months after it

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None