Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04846114
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-04-11
Brief Title:
Dental Implants in Patients Under Oral Anticoagulant Therapy
Sponsor:
Jorge Ernesto Aguilar
Organization:
Universidad del Salvador Argentina
Study Overview
Official Title:
Efficacy of Local Hemostatic Management in Implant Surgery in Anticoagulated Patients on Warfarin a Randomized Clinical Study
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
This study evaluated the outcomes in the post-operative recovery following dental implant surgery in patients who continued on oral anticoagulated therapy OAT with warfarin The primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery and presence of intraoralextraoral hematomas in skin and mucosa oral
Detailed Description:
The aim of this study was compare 1 the frequency of immediate and short term postoperative bleeding using tranexamic acid TXAg bismuth subgallate BSg or dry gauze DGg as local hemostatic 2 explore the relation between bleeding and the occurrence of hematomas with length of incision duration of surgery and alveolar ridge recontouring 80 surgical procedures performed in a total of 71 patients 20 surgical procedures in 18 patients not on OAT and 60 surgical procedures performed in 53 patients on OAT that were assigned to one of four groups so that each group included 20 procedures The control group Cg comprised 20 procedures performed in patients not on OAT The 60 procedures to be performed in patients on OAT were randomly to one of the three following experimental groups 1 TXAg group OAT plus TXA as local hemostatic agent 2 BSg group OAT plus BS as local hemostatic agent 3 DGg group OAT plus compression with dry gauze as local hemostatic agent Outcomes variables were
Intraoperative variables length of incision expressed Li alveolar ridge recontouring Arr total duration of surgery Ds surgical quadrant and implant location
Postoperative variables immediate postoperative bleeding within the first 30 minutes after surgery short-term bleeding within the first 5 days post-surgery determined according to the index described by Bacci presence of intraoralextraoral hematomas in skin or mucosa Descriptive statistical analysis of variance and regression logistic analysis was performed Statistical significance was set at a value of p005
Intraoperative variables length of incision expressed Li alveolar ridge recontouring Arr total duration of surgery Ds surgical quadrant and implant location
Postoperative variables immediate postoperative bleeding within the first 30 minutes after surgery short-term bleeding within the first 5 days post-surgery determined according to the index described by Bacci presence of intraoralextraoral hematomas in skin or mucosa Descriptive statistical analysis of variance and regression logistic analysis was performed Statistical significance was set at a value of p005
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