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.
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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Oral gel applied locally on the MRONJ related lesions or post-extraction sockets
Oral gel applied locally on the MRONJ related lesions or post-extraction sockets
AOU Policlinico G. Rodolico
Catania, CT, Italy
Oral Health Impact Profile Short Form (OHIP-14)
4-point scale in which the presence or absence of physical pain, functional limitation, psychological distress, physical, psychological and social disability and handicap is analyzed
Time frame: 6 months
Alveolar bone resorption
Amount of vertical alveolar resorption expressed in mm
Time frame: 6 months
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