Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study
Primary Purpose
Aphthous Stomatitis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
zinc sulphate 220mg/day in one dosage
placebo: one dosage
Sponsored by
About this trial
This is an interventional treatment trial for Aphthous Stomatitis focused on measuring Recurrent aphthous stomatitis, treatment, zinc sulphate
Eligibility Criteria
Inclusion Criteria:
- A history of Recurrent aphthous stomatitis
- Patients who had symptoms such as burning sensation, pain
- Patients not on any immunosuppressive or immunomodulatory treatment .
- Patients of both sexes over 10 years with recurrent aphthous stomatitis
- Patients who gave written informed consent
- Patients who were willing for evaluation after therapy and every 1 month up to 5months
Exclusion Criteria:
- Participants demonstrating drug consumption in the 7 past months
- pregnancy or lactation
- Any kind of localized or systemic disease, especially ulcerative colitis , chorn disease and Bechet's syndrome
- Smokers
- patients receiving immunosuppressive treatments or any kind of systemic or local drugs especially systemic antibiotics (in past 2 weeks ) and oral antihistamines( in past month ) were either eliminated or asked to discontinue their treatment for a minimum of one month before entering the investigation.
Sites / Locations
- Qazvin university of medical sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
Patients with Recurrent aphthous stomatitis
Patients with Recurrent aphthous stomatitis
Outcomes
Primary Outcome Measures
improvment of Recurrent Aphthous Ulcerations
To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale
Secondary Outcome Measures
Relief sign &symptom
relief clinical features
Full Information
NCT ID
NCT01210014
First Posted
September 2, 2010
Last Updated
September 27, 2010
Sponsor
Qazvin University Of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01210014
Brief Title
Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study
Official Title
Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Qazvin University Of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Recurrent aphthous stomatitis (RAS) is one of the most common of oral mucosa diseases that affects approximately 20% of the general population. Despite the fact that clinical, pathologic and therapeutic feature of the disease has been comprehensively studied, the pathophysiology of aphthous ulcers remains incompletely understood.
Zinc is a potent catalyst of wound healing and zinc deficiency may be a common cause of delayed tissue repair. Use of zinc sulfate in promotion wound healing and preservation of epithelial integrity advocated its possible use in the treatment or prevention of recurrent oral ulcers.
The purpose of the present study was to determine of systemic zinc sulphate in the treatment of recurrent aphthous stomatitis.
Detailed Description
Recurrent aphthous stomatitis (RAS) is a chronic inflammatory disease of man characterized by painful ulceration recurring with varying frequency. The pathophysiology of aphthous ulcers remains partly understood. The primary disorder appears to be the result of activation of the cell-mediated immune system. Aphthous ulcers may have abnormalities in cell communication and epithelial integrity. The diagnosis of aphthous ulcers is primarily clinical. Aphthous ulcers occur on areas of nonkeratinized mucosa of the mouth particularly the buccal mucosa, the labial mucosa, the floor of the mouth, the ventral surface of the tongue, and the soft palate. The treatment of recurrent aphthous stomatitis (RAS) still remains unclear and is based mainly on experimental data. The purpose of therapy include the management of pain and functional injury by suppressing inflammatory responses, in addition to reducing the frequency of recurrences or keeping away from the onset of new ulcers .Zinc has been identified as an important factor in repair of tissue.After considerable searching zinc was recognized as the beneficial impurity and a effective factor in healing .The goal of this study is to present the efficiency of dietary zinc supplements in the rate of Recurrent aphthous stomatitis healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis
Keywords
Recurrent aphthous stomatitis, treatment, zinc sulphate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Patients with Recurrent aphthous stomatitis
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients with Recurrent aphthous stomatitis
Intervention Type
Drug
Intervention Name(s)
zinc sulphate 220mg/day in one dosage
Intervention Description
patients with clinical signs and symptoms of RAS , in whom clinical diagnosis was accompanied with low level of zinc serum were selected for the study. Gender, age, medical history, symptoms, types and site, number, size, pain level, intervals, disease duration and form of treatment were recorded for all participants. Patients were randomly divided into two groups . The case group (n=7) received a single dose of zinc sulphate in the form of 220 mg capsules for 1 month ,while starch-containing placebo was administered with the same dosage and period in the control group.
The clinical data were scored according to the size of lesions were scored subjectively.
the symptomatology score was obtained using a visual analogue scale(VAS). All participants in both groups were examined up to 5 months in order to assess the effectiveness of the treatment. At the end of fifth month the serum zinc level was tested again.
Intervention Type
Drug
Intervention Name(s)
placebo: one dosage
Intervention Description
patients with clinical signs and symptoms of RAS , in whom clinical diagnosis was accompanied with low level of zinc serum were selected for the study. Gender, age, medical history, symptoms, types and site, number, size, pain level, intervals, disease duration and form of treatment were recorded for all participants. Patients were randomly divided into two groups . The case group (n=7) received a single dose of zinc sulphate in the form of 220 mg capsules for 1 month ,while starch-containing placebo was administered with the same dosage and period in the control group.
The clinical data were scored according to the size of lesions were scored subjectively.
the symptomatology score was obtained using a visual analogue scale(VAS). All participants in both groups were examined up to 5 months in order to assess the effectiveness of the treatment. At the end of fifth month the serum zinc level was tested again.
Primary Outcome Measure Information:
Title
improvment of Recurrent Aphthous Ulcerations
Description
To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Relief sign &symptom
Time Frame
5 months
Title
relief clinical features
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A history of Recurrent aphthous stomatitis
Patients who had symptoms such as burning sensation, pain
Patients not on any immunosuppressive or immunomodulatory treatment .
Patients of both sexes over 10 years with recurrent aphthous stomatitis
Patients who gave written informed consent
Patients who were willing for evaluation after therapy and every 1 month up to 5months
Exclusion Criteria:
Participants demonstrating drug consumption in the 7 past months
pregnancy or lactation
Any kind of localized or systemic disease, especially ulcerative colitis , chorn disease and Bechet's syndrome
Smokers
patients receiving immunosuppressive treatments or any kind of systemic or local drugs especially systemic antibiotics (in past 2 weeks ) and oral antihistamines( in past month ) were either eliminated or asked to discontinue their treatment for a minimum of one month before entering the investigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kataun Borhanmojabi, DDS,MSC
Organizational Affiliation
QUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Touba Karagah, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reza Mortazavi, PHD
Organizational Affiliation
QUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samira Ganbarzade, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qazvin university of medical sciences
City
Qazvin
ZIP/Postal Code
3415759811
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study
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