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

NCT06409546 | Completed

• 1 other identifier: 121-31
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Medically Related Osteonecrosis of the Jaws

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Alveolar bone resorption

  6 months

Study Arms (2)

Tocopherol 75% and pentoxifilline 5% gel

ACTIVE COMPARATOR

Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5%

Drug: Tocopherol and pentoxifilline topical gel

Placebo gel

PLACEBO COMPARATOR

Patients treated with a topical placebo gel control

Drug: Placebo

Interventions

Tocopherol and pentoxifilline topical gel DRUG

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

Tocopherol 75% and pentoxifilline 5% gel

Placebo DRUG

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

Placebo gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, CT, 95124, Italy

Location

MeSH Terms

Interventions

Tocopherols

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: April 2, 2020
• Primary Completion: December 17, 2023
• Study Completion: January 24, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months
• Access Criteria: Pubmed

Locations

IT (1)