Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409546
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws
Sponsor:
University of Catania
Organization:
University of Catania
Study Overview
Official Title:
Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-05
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:
While there is no doubt about the benefits of antiresorptives it is known that patients using these drugs are at increased risk of developing osteonecrosis of the jaws MRNOJ especially after oral procedures such as tooth extraction The management of osteonecrosis has remained a controversial topic within the oral and maxillofacial surgery community
The aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ
The aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ
Detailed Description:
A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ and determine the statistical significance of the outcome variables
48 subjects with MRNOJ randomly allocated in two groups placebo group with a 4 hydroxyethyl cellulose adhesive gel and the treatment group with the same gel containing pentoxifilline 5 and tocopherol 75
48 subjects with MRNOJ randomly allocated in two groups placebo group with a 4 hydroxyethyl cellulose adhesive gel and the treatment group with the same gel containing pentoxifilline 5 and tocopherol 75
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