Trial record 13 of 17 for:    "Aphthous stomatitis"

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

This study is ongoing, but not recruiting participants.
Tanta University
Information provided by (Responsible Party):
Amr Moustafa Elkhouli, October 6 University Identifier:
First received: April 5, 2013
Last updated: April 10, 2013
Last verified: April 2013

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

Condition Intervention Phase
Recurrent Mouth Ulcers
Drug: omega-3
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Further study details as provided by October 6 University:

Primary Outcome Measures:
  • quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]
    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:
  • Pain associated with the ulcers [ Time Frame: Six months ] [ Designated as safety issue: No ]
    The measurements for treatment effectiveness included evaluation of pain associated with the ulcer(s) by means of visual analogue scales (VAS).

  • Duration of ulcers episode [ Time Frame: Six months ] [ Designated as safety issue: No ]
    The time needed for the ulcer to heal

  • The monthly number of ulcer outbreaks [ Time Frame: Monthly for six months ] [ Designated as safety issue: No ]
    The number of ulcers appears monthly in the mouth

Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   13 Years to 70 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its identifier: NCT01831453

October 6 university
Cairo, Governarate of 6 of October, Egypt, 11348
Sponsors and Collaborators
October 6 University
Tanta University
Principal Investigator: Amr M Elkhouli, ass prof October 6 University
  More Information

Additional Information:
Responsible Party: Amr Moustafa Elkhouli, Associate professor, October 6 University Identifier: NCT01831453     History of Changes
Other Study ID Numbers: Dr. Amr Elkhouli 1962
Study First Received: April 5, 2013
Last Updated: April 10, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by October 6 University:
recurrent aphthous stomatitis
quality of life

Additional relevant MeSH terms:
Stomatitis, Aphthous
Oral Ulcer
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes processed this record on April 17, 2014