Recurrent Mouth Ulcers Clinical Trial
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.
| Verified date | April 2013 |
| Source | October 6 University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Egypt: Institutional Review Board |
| Study type | Interventional |
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | May 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Egypt | October 6 university | Cairo | Governarate of 6 of October |
| Lead Sponsor | Collaborator |
|---|---|
| October 6 University | Tanta University |
Egypt,
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-ß42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | quality of life | 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. | six months | No |
| Secondary | Pain associated with the ulcers | The measurements for treatment effectiveness included evaluation of pain associated with the ulcer(s) by means of visual analogue scales (VAS). | Six months | No |
| Secondary | Duration of ulcers episode | The time needed for the ulcer to heal | Six months | No |
| Secondary | The monthly number of ulcer outbreaks | The number of ulcers appears monthly in the mouth | Monthly for six months | No |