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

Purpose

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.

Condition	Intervention	Phase
Aphthous Stomatitis	Drug: zinc sulphate 220mg/day in one dosage Drug: placebo: one dosage	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis

Resource links provided by NLM:

MedlinePlus related topics: Canker Sores

Drug Information available for: Zinc Sulfate Sulfate ion

U.S. FDA Resources

Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:

improvment of Recurrent Aphthous Ulcerations [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale

Secondary Outcome Measures:

Relief sign &symptom [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
relief clinical features [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment:	14
Study Start Date:	April 2008
Study Completion Date:	August 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210014

Locations

Iran, Islamic Republic of
Qazvin university of medical sciences
Qazvin, Iran, Islamic Republic of, 3415759811

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Qazvin university of medical sciences (dental school), Qazvin university of medical sciences
ClinicalTrials.gov Identifier:	NCT01210014 History of Changes
Other Study ID Numbers:	QUMS320
Study First Received:	September 2, 2010
Last Updated:	September 27, 2010
Health Authority:	Iran: Ethics Committee

Keywords provided by Qazvin University Of Medical Sciences:

Recurrent aphthous stomatitis
treatment
zinc sulphate

Additional relevant MeSH terms:

Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Zinc
Zinc Sulfate
Trace Elements

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013