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

Not Applicable

Completed

• Conditions: Medically Related Osteonecrosis of the Jaws
• Interventions: Drug: Tocopherol and pentoxifilline topical gel; Drug: Placebo

• Registration Number: NCT06409546
• Lead Sponsor: University of Catania

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%.

Study Timeline

• Study Start: 2020-04-02
• Primary Completion: 2023-12-17
• Study Completion: 2024-01-24
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocopherol 75% and pentoxifilline 5% gel	Tocopherol and pentoxifilline topical gel	Patients treated with a topical gel of tocopherol 75% and pentoxifilline 5%
Placebo gel	Placebo	Patients treated with a topical placebo gel control

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Alveolar bone resorption	6 months	Amount of vertical alveolar resorption expressed in mm

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, CT, Italy