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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Ther

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

Detailed Summary: 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.
Sponsor: October 6 University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).
  • Duration of ulcers episode [ Time Frame: Six months ]
    The time needed for the ulcer to heal
  • The monthly number of ulcer outbreaks [ Time Frame: Monthly for six months ]
    The number of ulcers appears monthly in the mouth


Original Secondary Outcome: Same as current

Information By: October 6 University

Dates:
Date Received: April 5, 2013
Date Started: April 2012
Date Completion: May 2013
Last Updated: April 10, 2013
Last Verified: April 2013