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Management of Mandibular ORN: PENTO as Medical Treatment (PENTO)

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ClinicalTrials.gov Identifier: NCT02368457
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : December 20, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Miriam Martos-Fernandez, Hospital Vall d'Hebron

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Osteoradionecrosis
Intervention: Drug: Pentoxifylline and Tocopherol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pentoxifylline and Tocopherol

Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.

Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).

Control Group No drug treatment

Participant Flow:   Overall Study
    Pentoxifylline and Tocopherol   Control Group
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pentoxifylline and Tocopherol

Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.

Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).

Control Group No drug treatment
Total Total of all reporting groups

Baseline Measures
   Pentoxifylline and Tocopherol   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (10)   55  (10)   56  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  16.7%      2  16.7%      4  16.7% 
Male      10  83.3%      10  83.3%      20  83.3% 
Exposed bone 
[Units: Mm^2]
Mean (Standard Deviation)
 10  (10)   15  (10)   12.5  (10) 


  Outcome Measures

1.  Primary:   Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).   [ Time Frame: From baseline to 1, 3, 6, and 9 months of starting treatment ]

2.  Secondary:   Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale   [ Time Frame: From baseline to 1,3, 6, 9 months of starting treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Miriam Martos
Organization: Oral and Maxillofacial Surgeon
phone: +34932746179
e-mail: miryam.martos@gmail.com


Publications:

Responsible Party: Miriam Martos-Fernandez, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT02368457     History of Changes
Other Study ID Numbers: ORN-2014-16
First Submitted: February 10, 2015
First Posted: February 23, 2015
Results First Submitted: February 18, 2016
Results First Posted: December 20, 2016
Last Update Posted: March 22, 2018