ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Combination Treatment of Pentoxifylline and Tocopherol Provides Promising New Treatment Modality for Patients Suffering from Osteoradionecrosis of the Jaw
Clinical Question For patients with osteoradionecrosis of the jaw (ORN), would the combination treatment of pentoxifylline (PTX) and tocopherol (vitamin E) result in improved healing rates as compared to the standard treatment of hyperbaric oxygen therapy?
Clinical Bottom Line For patients suffering from osteoradionecrosis of the jaws, initial evidence on the combination therapy of PTX and tocopherol shows higher healing success rates than the accepted treatment of hyperbaric oxygen dives. The evidence to support the treatment of PTX and tocopherol is limited to clinical trials and retrospective case series. The treatment is not widely accepted amongst dental professionals, despite promising success rates and low adverse patient effects. Additional clinical evidence, especially long-term efficacy studies, is needed to validate initial clinical trials.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 26084886Hayashi/201513 ORN patientsCase series
Key results11 of the 13 patients treated with 400 mg PTX BID and 1000 mg tocopherol QD showed evidence of improvement and healing with an average treatment time of 13.5 months.
#2) 28034471Lyons/2017ORN patients treated with PTX or PTX combinationNarrative review
Key resultsThe results of 8 studies were reviewed in a table, showing that PTX (often in combination with other drugs), has a 50%-96% success rate in improving ORN condition in patients. The pharmacology and mechanisms of action of PTX, tocopherol, and clodronate were explained in depth as well.
#3) 20638190DeLanian/201154 ORN patientsClinical Trial
Key resultsThe “PENTOCLO” protocol was shown to be a clinically safe and well-tolerated treatment regimen in a Phase II trial, with 96% of patients in the study (54) experiencing a significant amount of reduction in exposed bone after 18 months.
Evidence Search “Pentoxifylline” [MeSH] AND “Osteoradionecrosis” [MeSH], OR “Pentoxifylline AND Tocopherol” [MeSH], OR “Osteoradionecrosis healing” [MeSH]
Comments on
The Evidence
Validity: Due to lack of prospective randomized controlled trials, systematic reviews, and meta-analyses of the subject, the strength of the available evidence is low. However, in the clinical trials mentioned, research methods were well-documented and comprehensive. Perspective: High quality research has been performed on the subject, but not enough clinical trials have been completed for the combination of Pentoxifylline and Tocopherol to become an accepted treatment modality for ORN.
Applicability This evidence has limited applicability to a small sub-group of the population, mostly applying to patients who have undergone radiation treatment for head and neck cancer. It is not currently an accepted treatment modality for ORN.
Specialty/Discipline (Oral Medicine/Pathology/Radiology) (General Dentistry) (Oral Surgery) (Periodontics) (Prosthodontics) (Restorative Dentistry)
Keywords Pentoxifylline, tocopherol, osteoradionecrosis
ID# 3296
Date of submission: 11/28/2017spacer
E-mail ThomasMS@livemail.uthscsa.edu
Author Melissa Thomas, D.D.S
Co-author(s) Troy Decker, D.D.S
Co-author(s) e-mail DeckerT@livemail.uthscsa.edu
Faculty mentor/Co-author
Faculty mentor/Co-author e-mail
Basic Science Rationale
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