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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocopherol 75% and pentoxifilline 5% gel | Active Comparator | Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5% |
|
| Placebo gel | Placebo Comparator | Patients treated with a topical placebo gel control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocopherol and pentoxifilline topical gel | Drug | Oral gel applied locally on the MRONJ related lesions or post-extraction sockets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar bone resorption | Amount of vertical alveolar resorption expressed in mm | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Catania | CT | 95124 | Italy |
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6 months
Pubmed
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Sealed envelopes
| Placebo | Drug | Oral gel applied locally on the MRONJ related lesions or post-extraction sockets |
|
| ID | Term |
|---|---|
| D024505 | Tocopherols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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