Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study

Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis

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.

Study Overview

• Status: Completed
• Conditions: Aphthous Stomatitis
• Intervention / Treatment: Drug: placebo: one dosage; Drug: zinc sulphate 220mg/day in one dosage

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of, 3415759811
    • Qazvin University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A history of Recurrent aphthous stomatitis
2. Patients who had symptoms such as burning sensation, pain
3. Patients not on any immunosuppressive or immunomodulatory treatment .
4. Patients of both sexes over 10 years with recurrent aphthous stomatitis
5. Patients who gave written informed consent
6. Patients who were willing for evaluation after therapy and every 1 month up to 5months

Exclusion Criteria:

1. Participants demonstrating drug consumption in the 7 past months
2. pregnancy or lactation
3. Any kind of localized or systemic disease, especially ulcerative colitis , chorn disease and Bechet's syndrome
4. Smokers
5. 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.

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: A; Patients with Recurrent aphthous stomatitis	Drug: placebo: one dosage; 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.
Active Comparator: B; Patients with Recurrent aphthous stomatitis	Drug: zinc sulphate 220mg/day in one dosage; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvment of Recurrent Aphthous Ulcerations	To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Relief sign &symptom	5 months
relief clinical features	5 months

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences
• Investigators: Study Chair: Kataun Borhanmojabi, DDS,MSC, QUMS; Principal Investigator: Touba Karagah, DDS, QUMS; Study Director: Reza Mortazavi, PHD, QUMS; Principal Investigator: Samira Ganbarzade, DDS, QUMS

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 27, 2010
• First Posted (Estimate): September 28, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2010
• Last Update Submitted That Met QC Criteria: September 27, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: treatment; Recurrent aphthous stomatitis; zinc sulphate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Aphthous; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• Other Study ID Numbers: QUMS320