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Completed

NCT Number: NCT06409546

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

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.

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Key information

Conditions

Medically Related Osteonecrosis of the Jaws

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, CT, 95124, Italy

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocopherol and pentoxifilline topical gel

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Alveolar bone resorption

    Time frame: 6 months

    Amount of vertical alveolar resorption expressed in mm

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 10, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.