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

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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

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.

Study Phase

Phase 2

Study Type


Primary Outcome

improvment of Recurrent Aphthous Ulcerations

Secondary Outcome

 Relief sign &symptom


Aphthous Stomatitis


zinc sulphate 220mg/day in one dosage

Study Arms / Comparison Groups

Description:  Patients with Recurrent aphthous stomatitis


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

April 2008

Completion Date

August 2009

Primary Completion Date

April 2009

Eligibility Criteria

        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.




10 Years - N/A

Accepts Healthy Volunteers



Kataun Borhanmojabi, DDS,MSC, , 

Location Countries

Iran, Islamic Republic of

Location Countries

Iran, Islamic Republic of

Administrative Informations



Organization ID


Study Sponsor

Qazvin University Of Medical Sciences

Study Sponsor

Kataun Borhanmojabi, DDS,MSC, Study Chair, QUMS

Verification Date

September 2010