Viewing Study NCT06334770



Ignite Creation Date: 2024-05-06 @ 8:19 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06334770
Status: COMPLETED
Last Update Posted: 2024-03-28
First Post: 2024-03-20

Brief Title: Influence of Roxolid Implant Material on the Implant Stability Implant Stability
Sponsor: Ain Shams University
Organization: Ain Shams University

Study Overview

Official Title: Influence of Roxolid Implant Material on the Implant Stability of Maxillary Implant Retained Overdenture
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
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: BLX
Brief Summary: Fourteen completely edentulous patients were selected to participate in this study From the outpatient clinic of Prosthodontic Department Faculty of Dentistry Ain Shams University

After fabrication of complete denture for all patients patients were randomly divided to

Group A Seven patients were rehabilitated with implant retained maxillary overdenture where four Straumann BLX implant were inserted opposed by mandibular complete denture

Group B Seven patients were rehabilitated with implant retained maxillary overdenture where four conventional acid etched implants were inserted opposed by mandibular complete denture

After implant placement using surgical guide smart peg and ostell device were used to measure the primary stability of the implant then cover screw was placed and after six weeks secondary stability was measured for both groups

After four months the second stage started in which exposure of the implant fixtures took place and pick up was carried out

Patients were recalled frequently for post-insertion inspection and adjustment
Detailed Description: Background long term success of implant restoration depends on many factors one of them is the sufficient implant stability which is lowered in compromised bone density sites such as the maxilla which is categorized as type III IV bone so searching for new innovation and updates in implant material and features is very mandatory So the aim of this study was asses and compare between two implant materials roxolid versus traditional titanium on the primary and secondary stability

Methods eighteen completely edentulous patients were selected they all received maxillary implant retained overdentures and lower complete dentures they were divided equally in to two groups according to the type of the material of the implants Group A received a total number of 36 Roxolid Implants were made of roxolid material and Group B received a total number 36 Titanium implants were made of traditional titanium alloys Implant stability was assed using ostell device the primary implant stability was measured at the day of implant installation however secondary implant stability was measured after six weeks of implant placement Paired t-test was used to compare between primary and secondary stability in the same group and independent t-test was used to compare between the two groups with a significant level 005

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