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

NCT ID: NCT06409546

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2024-01-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medically Related Osteonecrosis of the Jaws

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Sealed envelopes

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tocopherol 75% and pentoxifilline 5% gel

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

Group Type ACTIVE_COMPARATOR

Tocopherol and pentoxifilline topical gel

Intervention Type DRUG

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

Placebo gel

Patients treated with a topical placebo gel control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tocopherol and pentoxifilline topical gel

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Catania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Policlinico G. Rodolico

Catania, CT, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

121-31

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Coenzyme Q10 and Dentoalveolar Cyst
NCT05873673 ACTIVE_NOT_RECRUITING PHASE2