Trial Outcomes & Findings for Management of Mandibular ORN: PENTO as Medical Treatment (NCT NCT02368457)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

From baseline to 1, 3, 6, and 9 months of starting treatment

Results posted on

2018-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management of Mandibular ORN: PENTO as Medical Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pentoxifylline and Tocopherol n=12 Participants 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 n=12 Participants No drug treatment	Total n=24 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 10 • n=99 Participants	55 years STANDARD_DEVIATION 10 • n=107 Participants	56 years STANDARD_DEVIATION 10 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Exposed bone	10 mm^2 STANDARD_DEVIATION 10 • n=99 Participants	15 mm^2 STANDARD_DEVIATION 10 • n=107 Participants	12.5 mm^2 STANDARD_DEVIATION 10 • n=206 Participants

PRIMARY outcome

Timeframe: From baseline to 1, 3, 6, and 9 months of starting treatment

Population: mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment

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.

Outcome measures

Outcome measures
Measure	Pentoxifylline and Tocopherol n=12 Participants 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 n=12 Participants Standard treatment
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG). 1 month of starting treatment	14 mm2 Interval 10.0 to 18.0	15 mm2 Interval 10.0 to 20.0
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG). 3 month of starting treatment	13 mm2 Interval 10.0 to 16.0	15 mm2 Interval 10.0 to 20.0
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG). 6 month of starting treatment	11.5 mm2 Interval 10.0 to 13.0	15 mm2 Interval 10.0 to 20.0
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG). 9 month of starting treatment	10 mm2 Interval 8.0 to 12.0	15 mm2 Interval 10.0 to 20.0

SECONDARY outcome

Timeframe: From baseline to 1,3, 6, 9 months of starting treatment

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.

Outcome measures

Outcome measures
Measure	Pentoxifylline and Tocopherol n=12 Participants 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 n=12 Participants Standard treatment
Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale 1 month of starting treatment	14.5 units on a scale Interval 13.2 to 15.8	15.5 units on a scale Interval 14.0 to 17.0
Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale 3 month of starting treatment	14 units on a scale Interval 13.0 to 15.0	15.5 units on a scale Interval 14.0 to 17.0
Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale 6 month of starting treatment	14 units on a scale Interval 13.0 to 15.0	15.5 units on a scale Interval 14.0 to 17.0
Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale 9 month of starting treatment	13.3 units on a scale Interval 12.0 to 14.6	15.5 units on a scale Interval 14.0 to 17.0

Adverse Events

Pentoxifylline and Tocopherol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Miriam Martos

Oral and Maxillofacial Surgeon

Phone: +34932746179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place