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

Phase 2

• Conditions: Recurrent Mouth Ulcers
• Interventions: Drug: placebo; Drug: omega-3

• Registration Number: NCT01831453
• Lead Sponsor: October 6 University

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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Study First Posted: 2013-04-15
• Last Update Posted: 2013-04-15
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isopropylmyristate oil	placebo	placebo Soft gelatinous capsules filled with isopropylmyristate oil
experimental	omega-3	omega-3 1 gram three times daily for 6 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

October 6 university; 🇪🇬 Cairo, Governarate of 6 of October, Egypt