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| Name | Class |
|---|---|
| Tanta University | OTHER |
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The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isopropylmyristate oil | Placebo Comparator | placebo Soft gelatinous capsules filled with isopropylmyristate oil |
|
| experimental | Active Comparator | omega-3 1 gram three times daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 | Drug | polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of ulcers episode |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Amr M Elkhouli, ass prof | October 6 University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| October 6 university | Cairo | Governarate of 6 of October | 11348 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23481688 | Background | 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-beta42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131. |
| Label | URL |
|---|---|
| alzheimers | View source |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D005395 | Fish Oils |
| C008205 | isopropyl myristate |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| placebo | Drug | soft gelatinous capsules filled with isopropylmyristate oil |
|
|
The time needed for the ulcer to heal
| Six months |
| The monthly number of ulcer outbreaks | The number of ulcers appears monthly in the mouth | Monthly for six months |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |