NCT06409546

Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws

Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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%.

Conditions

• Medically Related Osteonecrosis of the Jaws

Interventions

Type	Name	Description
DRUG	Tocopherol and pentoxifilline topical gel	Oral gel applied locally on the MRONJ related lesions or post-extraction sockets
DRUG	Placebo	Oral gel applied locally on the MRONJ related lesions or post-extraction sockets

Timeline

• Start date: 2020-04-02
• Primary completion: 2023-12-17
• Completion: 2024-01-24
• First posted: 2024-05-10
• Last updated: 2024-05-10

Locations

1 site across 1 country: Italy