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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
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pentoxifylline and Tocopherol Control Group
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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).

No drug treatment
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Pentoxifylline and Tocopherol Control Group Total
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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).

No drug treatment Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
57  (10) 55  (10) 56  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
2
  16.7%
2
  16.7%
4
  16.7%
Male
10
  83.3%
10
  83.3%
20
  83.3%
Exposed bone  
Mean (Standard Deviation)
Unit of measure:  Mm^2
Number Analyzed 12 participants 12 participants 24 participants
10  (10) 15  (10) 12.5  (10)
1.Primary Outcome
Title Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).
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Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).

Intraoral bone exposure is measured in mm2.

Time Frame From baseline to 1, 3, 6, and 9 months of starting treatment
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Hide Analysis Population Description
mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment
Arm/Group Title Pentoxifylline and Tocopherol Control Group
Hide Arm/Group Description:

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).

Standard treatment
Overall Number of Participants Analyzed 12 12
Mean (Full Range)
Unit of Measure: mm2
1 month of starting treatment
14
(10 to 18)
15
(10 to 20)
3 month of starting treatment
13
(10 to 16)
15
(10 to 20)
6 month of starting treatment
11.5
(10 to 13)
15
(10 to 20)
9 month of starting treatment
10
(8 to 12)
15
(10 to 20)
2.Secondary Outcome
Title Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale
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Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).

To examine the LENT/SOMA scale prospectively using interviews and questionnaires

Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.

Maximum score: 36 Minimum score: 0

Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.

Scale categories:

Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.

Time Frame From baseline to 1,3, 6, 9 months of starting treatment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pentoxifylline and Tocopherol CONTROL
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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).

No drug treatment
Overall Number of Participants Analyzed 12 12
Mean (Full Range)
Unit of Measure: units on a scale
1 month of starting treatment
14.5
(13.2 to 15.8)
15.5
(14 to 17)
3 month of starting treatment
14
(13 to 15)
15.5
(14 to 17)
6 month of starting treatment
14
(13 to 15)
15.5
(14 to 17)
9 month of starting treatment
13.3
(12 to 14.6)
15.5
(14 to 17)
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pentoxifylline and Tocopherol Control Group
Hide Arm/Group Description

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).

Standard treatment
All-Cause Mortality
Pentoxifylline and Tocopherol Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pentoxifylline and Tocopherol Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pentoxifylline and Tocopherol Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
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
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