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

NCT ID: NCT01210014

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Aphthous Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Patients with Recurrent aphthous stomatitis

Group Type PLACEBO_COMPARATOR

placebo: one dosage

Intervention Type DRUG

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.

B

Patients with Recurrent aphthous stomatitis

Group Type ACTIVE_COMPARATOR

zinc sulphate 220mg/day in one dosage

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Qazvin university of medical sciences

Principal Investigators

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Kataun Borhanmojabi, DDS,MSC

Role: STUDY_CHAIR

QUMS

Touba Karagah, DDS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Reza Mortazavi, PHD

Role: STUDY_DIRECTOR

QUMS

Samira Ganbarzade, DDS

Role: PRINCIPAL_INVESTIGATOR

QUMS

Locations

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Qazvin university of medical sciences

Qazvin, Qazvin Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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QUMS320

Identifier Type: -

Identifier Source: org_study_id