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

Aphthous Stomatitis Clinical Trial

Official title:

Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210014
• Other study ID #: QUMS320
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2010
• Last updated: September 27, 2010
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2010
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin university of medical sciences	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvment of Recurrent Aphthous Ulcerations	To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale	5 months	Yes
Secondary	Relief sign &symptom		5 months	Yes
Secondary	relief clinical features		5 months	Yes