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

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

Detailed Description
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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.

Official Title
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Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.

Conditions
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Recurrent Mouth Ulcers

Intervention / Treatment
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* Drug: omega-3
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: isopropylmyristate oil<br>placebo Soft gelatinous capsules filled with isopropylmyristate oil | Drug: placebo<br>* soft gelatinous capsules filled with isopropylmyristate oil<br>* Other names: isopropylmyristate oil;|
| Active Comparator: experimental<br>omega-3 1 gram three times daily for 6 months | Drug: omega-3<br>* polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months<br>* Other names: fish oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3, recurrent aphthous stomatitis, quality of life