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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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

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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.

Conditions

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Recurrent Mouth Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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isopropylmyristate oil

placebo Soft gelatinous capsules filled with isopropylmyristate oil

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

soft gelatinous capsules filled with isopropylmyristate oil

experimental

omega-3 1 gram three times daily for 6 months

Group Type ACTIVE_COMPARATOR

omega-3

Intervention Type DRUG

polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months

Interventions

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omega-3

polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months

Intervention Type DRUG

placebo

soft gelatinous capsules filled with isopropylmyristate oil

Intervention Type DRUG

Other Intervention Names

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fish oil isopropylmyristate oil

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No