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Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01831453
Recruitment Status : Unknown
Verified April 2013 by Amr Moustafa Elkhouli, October 6 University.
Recruitment status was:  Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : April 15, 2013
Tanta University
Information provided by (Responsible Party):
Amr Moustafa Elkhouli, October 6 University

Brief Summary:
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers

Condition or disease Intervention/treatment Phase
Recurrent Mouth Ulcers Drug: omega-3 Drug: placebo Phase 2

Detailed Description:
In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
Study Start Date : April 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

Arm Intervention/treatment
Placebo Comparator: isopropylmyristate oil
placebo Soft gelatinous capsules filled with isopropylmyristate oil
Drug: placebo
soft gelatinous capsules filled with isopropylmyristate oil
Other Name: isopropylmyristate oil

Active Comparator: experimental
omega-3 1 gram three times daily for 6 months
Drug: omega-3
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
Other Name: fish oil

Primary Outcome Measures :
  1. quality of life [ Time Frame: six months ]
    Measurement of oral health related quality of life (OHR-QoL),this parameter was carried out at baseline, and at 6 months of the study using the Arabic version of oral health impact profile-14 (OHIP-14) questionnaire.

Secondary Outcome Measures :
  1. Pain associated with the ulcers [ Time Frame: Six months ]
    The measurements for treatment effectiveness included evaluation of pain associated with the ulcer(s) by means of visual analogue scales (VAS).

  2. Duration of ulcers episode [ Time Frame: Six months ]
    The time needed for the ulcer to heal

  3. The monthly number of ulcer outbreaks [ Time Frame: Monthly for six months ]
    The number of ulcers appears monthly in the mouth

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female patients older than 13 years of age
  2. Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
  3. History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
  4. Normal sense of pain, without anesthesia or paresthesia.
  5. Willingness to participate and sign the informed consent.

Exclusion Criteria:

  • 1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.

    2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.

    4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.

    5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01831453

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October 6 university
Cairo, Governarate of 6 of October, Egypt, 11348
Sponsors and Collaborators
October 6 University
Tanta University
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Principal Investigator: Amr M Elkhouli, ass prof October 6 University
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Responsible Party: Amr Moustafa Elkhouli, Associate professor, October 6 University Identifier: NCT01831453    
Other Study ID Numbers: Dr. Amr Elkhouli 1962
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013
Keywords provided by Amr Moustafa Elkhouli, October 6 University:
recurrent aphthous stomatitis
quality of life
Additional relevant MeSH terms:
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Stomatitis, Aphthous
Oral Ulcer
Mouth Diseases
Stomatognathic Diseases