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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Amr Moustafa Elkhouli, October 6 University
ClinicalTrials.gov Identifier:
NCT01831453
First received: April 5, 2013
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831453

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

Additional Information:
Publications:
Responsible Party: Amr Moustafa Elkhouli, Associate professor, October 6 University
ClinicalTrials.gov 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:
omega-3
recurrent aphthous stomatitis
quality of life

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Ulcer
Oral Ulcer
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014