Medically Related Osteonecrosis of the JawsNCT06409546
Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws
A study testing Tocopherol and pentoxifilline topical gel in people with Medically Related Osteonecrosis of the Jaws, run by University of Catania at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Medically Related Osteonecrosis of the Jaws
- What is being tested?
- Tocopherol and pentoxifilline topical gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2020to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Correspondence to the updated SIPMO criteria for MRONJ diagnosis
- Need for tooth extraction
Who cannot join
- Recent use of antibiotics and anti-inflammatories in the last 4 weeks
- Oral lesions of hard and soft tissues not related to MRONJ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial
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.
Read the detailed 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%.
- Being tested
- Tocopherol and pentoxifilline topical gel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocopherol and pentoxifilline topical gelDrug
Oral gel applied locally on the MRONJ related lesions or post-extraction sockets
PlaceboDrug
Oral gel applied locally on the MRONJ related lesions or post-extraction sockets
| Study group | Role | What they receive |
|---|---|---|
| Tocopherol 75% and pentoxifilline 5% gel | Active comparator | Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5% Receives: Drug: Tocopherol and pentoxifilline topical gel |
| Placebo gel | Placebo comparator | Patients treated with a topical placebo gel control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Alveolar bone resorption
Amount of vertical alveolar resorption expressed in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start2 Apr 2020
- Primary completion17 Dec 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medically Related Osteonecrosis of the JawsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409546
- Sponsor's protocol ID
- 121-31
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06409546
- Acronym / sponsor ID
- 121-31
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocopherol 75% and pentoxifilline 5% gel | Active comparator | Drug: Tocopherol and pentoxifilline topical gelPatients treated with a topical gel of tocopherol 75% and pentoxifilline 5% |
| Placebo gel | Placebo comparator | Drug: PlaceboPatients treated with a topical placebo gel control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Correspondence to the updated SIPMO criteria for MRONJ diagnosis
- Need for tooth extraction
Key exclusion criteria (2 listed)
- Recent use of antibiotics and anti-inflammatories in the last 4 weeks
- Oral lesions of hard and soft tissues not related to MRONJ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocopherol and pentoxifilline topical gelOral gel applied locally on the MRONJ related lesions or post-extraction sockets | Drug | Tocopherol 75% and pentoxifilline 5% gel |
| PlaceboOral gel applied locally on the MRONJ related lesions or post-extraction sockets | Drug | Placebo gel |
Primary outcome
Oral Health Impact Profile Short Form (OHIP-14)
Time frame: 6 months
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
1 secondary outcome
Alveolar bone resorption
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocopherol and pentoxifilline topical gel in people with Medically Related Osteonecrosis of the Jaws, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Impact Profile Short Form (OHIP-14) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.