An interventional study of Tocopherol and pentoxifilline topical gel and Placebo in Medically Related Osteonecrosis of the Jaws, sponsored by University of Catania. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by University of Catania · Not applicable, Interventional, and Treatment
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%.
184 studies on the registry are indexed under Osteonecrosis; 33 are open to participants now.
This study's enrollment of 48 is close to the median of 51 across 98 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →University of Catania is the lead sponsor of 68 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5%
Drug: Tocopherol and pentoxifilline topical gel
Patients treated with a topical placebo gel control
Drug: Placebo
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
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
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Catania