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

University of Catania

Status: Completed

Conditions: Medically Related Osteonecrosis of the Jaws

Treatments: Drug: Tocopherol and pentoxifilline topical gel; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06409546

121-31

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Correspondence to the updated SIPMO criteria for MRONJ diagnosis
• Need for tooth extraction

Exclusion criteria

• Recent use of antibiotics and anti-inflammatories in the last 4 weeks
• Oral lesions of hard and soft tissues not related to MRONJ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Tocopherol 75% and pentoxifilline 5% gel

Active Comparator group

Description:

Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5%

Treatment:

Drug: Tocopherol and pentoxifilline topical gel

Placebo gel

Placebo Comparator group

Description:

Patients treated with a topical placebo gel control

Treatment:

Drug: Placebo