Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws
Key facts
- Who runs it
- University of Catania
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 48 people enrolled
- Started
- 2 Apr 2020
- Ended
- 24 Jan 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Tocopherol and pentoxifilline topical gel
- Placebo
- Record updated
- 10 May 2024
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Correspondence to the updated SIPMO criteria for MRONJ diagnosis
- Need for tooth extraction
Who cannot take part
- Recent use of antibiotics and anti-inflammatories in the last 4 weeks
- Oral lesions of hard and soft tissues not related to MRONJ
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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The aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ.
The 2 groups in the trial
- Tocopherol 75% and pentoxifilline 5% gelExisting treatment, for comparison
Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5%
Treatment: Tocopherol and pentoxifilline topical gel
- Placebo gelPlacebo, for comparison
Patients treated with a topical placebo gel control
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial
- Record updated
- 10 May 2024