Recurrent Mouth Ulcers
Conditions
Keywords
omega-3, recurrent aphthous stomatitis, quality of life
Brief summary
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
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.
Interventions
DRUGomega-3
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
DRUGplacebo
soft gelatinous capsules filled with isopropylmyristate oil
Sponsors
Tanta University
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain associated with the ulcers | 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 | Six months | The time needed for the ulcer to heal |
| The monthly number of ulcer outbreaks | Monthly for six months | The number of ulcers appears monthly in the mouth |
Countries
Egypt
Outcome results
None listed