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

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

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

Study Overview

• Status: Unknown
• Conditions: Recurrent Mouth Ulcers
• Intervention / Treatment: Drug: placebo; Drug: omega-3

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Governarate of 6 of October
    • Cairo, Governarate of 6 of October, Egypt, 11348
      • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Tanta University
• Investigators: Principal Investigator: Amr M Elkhouli, ass prof, October 6 University

Publications and helpful links

General Publications

• 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.

Helpful Links

• alzheimers

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2013
• Last Update Submitted That Met QC Criteria: April 10, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: quality of life; recurrent aphthous stomatitis; omega-3
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Recurrence; Oral Ulcer; Stomatitis; Stomatitis, Aphthous
• Other Study ID Numbers: Dr. Amr Elkhouli 1962