Back to resultsOmega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
Primary Purpose
Recurrent Mouth Ulcers
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
omega-3
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Mouth Ulcers focused on measuring omega-3, recurrent aphthous stomatitis, quality of life
Eligibility Criteria
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.
Sites / Locations
- October 6 university
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
isopropylmyristate oil
experimental
Arm Description
placebo Soft gelatinous capsules filled with isopropylmyristate oil
omega-3 1 gram three times daily for 6 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Duration of ulcers episode
The time needed for the ulcer to heal
The monthly number of ulcer outbreaks
The number of ulcers appears monthly in the mouth
Full Information
NCT ID
NCT01831453
First Posted
April 5, 2013
Last Updated
April 10, 2013
Sponsor
October 6 University
Collaborators
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT01831453
Brief Title
Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
Official Title
Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Tanta University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Mouth Ulcers
Keywords
omega-3, recurrent aphthous stomatitis, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
isopropylmyristate oil
Arm Type
Placebo Comparator
Arm Description
placebo Soft gelatinous capsules filled with isopropylmyristate oil
Arm Title
experimental
Arm Type
Active Comparator
Arm Description
omega-3 1 gram three times daily for 6 months
Intervention Type
Drug
Intervention Name(s)
omega-3
Other Intervention Name(s)
fish oil
Intervention Description
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
isopropylmyristate oil
Intervention Description
soft gelatinous capsules filled with isopropylmyristate oil
Primary Outcome Measure Information:
Title
quality of life
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Pain associated with the ulcers
Description
The measurements for treatment effectiveness included evaluation of pain associated with the ulcer(s) by means of visual analogue scales (VAS).
Time Frame
Six months
Title
Duration of ulcers episode
Description
The time needed for the ulcer to heal
Time Frame
Six months
Title
The monthly number of ulcer outbreaks
Description
The number of ulcers appears monthly in the mouth
Time Frame
Monthly for six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Elkhouli, ass prof
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 university
City
Cairo
State/Province
Governarate of 6 of October
ZIP/Postal Code
11348
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
23481688
Citation
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.
Results Reference
background
Links:
URL
http://www.alzheimers.org/
Description
alzheimers
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Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
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