Trial record 9 of 17 for:
recurrent aphthous stomatitis
Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Amr Moustafa Elkhouli, October 6 University
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
Recurrent Mouth Ulcers
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
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
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Placebo Comparator: isopropylmyristate oil
placebo Soft gelatinous capsules filled with isopropylmyristate oil
soft gelatinous capsules filled with isopropylmyristate oil
Other Name: isopropylmyristate oil
Active Comparator: experimental
omega-3 1 gram three times daily for 6 months
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
Other Name: fish oil
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:
|Accepts Healthy Volunteers:
- Male and female patients older than 13 years of age
- Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
- History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
- Normal sense of pain, without anesthesia or paresthesia.
- Willingness to participate and sign the informed consent.
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.
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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
|October 6 university
|Cairo, Governarate of 6 of October, Egypt, 11348 |
October 6 University
||Amr M Elkhouli, ass prof
||October 6 University
Hjorth E, Zhu M, Toro VC, Vedin I, Palmblad J, Cederholm T, Freund-Levi Y, Faxen-Irving G, Wahlund LO, Basun H, Eriksdotter M, Schultzberg M. Omega-3 Fatty Acids Enhance Phagocytosis of Alzheimer's Disease-Related Amyloid-β42 by Human Microglia and Decrease Inflammatory Markers. J Alzheimers Dis. 2013 Mar 12. [Epub ahead of print]
||Amr Moustafa Elkhouli, Associate professor, October 6 University
History of Changes
|Other Study ID Numbers:
||Dr. Amr Elkhouli 1962
|Study First Received:
||April 5, 2013
||April 10, 2013
||Egypt: Institutional Review Board
Keywords provided by October 6 University:
recurrent aphthous stomatitis
quality of life
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014