Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws

Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06409546

Enrollment

Registered

2024-05-10

Start date

2020-04-02

Completion date

2024-01-24

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medically Related Osteonecrosis of the Jaws

Brief 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. 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%.

Interventions

DRUGTocopherol and pentoxifilline topical gel

Oral gel applied locally on the MRONJ related lesions or post-extraction sockets

DRUGPlacebo

Oral gel applied locally on the MRONJ related lesions or post-extraction sockets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Sealed envelopes

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Correspondence to the updated SIPMO criteria for MRONJ diagnosis * Need for tooth extraction

Exclusion criteria

* Recent use of antibiotics and anti-inflammatories in the last 4 weeks * Oral lesions of hard and soft tissues not related to MRONJ

Design outcomes

Primary

Measure	Time frame	Description
Oral Health Impact Profile Short Form (OHIP-14)	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

Secondary

Measure	Time frame	Description
Alveolar bone resorption	6 months	Amount of vertical alveolar resorption expressed in mm

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026