Clinical trial NCT01210014: Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study
Official title: Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aphthous Stomatitis
Keywords: Recurrent aphthous stomatitis
treatment
zinc sulphate
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 14
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: improvment of Recurrent Aphthous Ulcerations
timeFrame: 5 months
Secondary outcomes:
measure: Relief sign &symptom
timeFrame: 5 months
measure: relief clinical features
timeFrame: 5 months
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical sciences
Study officials:
affiliation: QUMS
name: Kataun Borhanmojabi, DDS,MSC
role: STUDY_CHAIR
affiliation: QUMS
name: Touba Karagah, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: QUMS
name: Reza Mortazavi, PHD
role: STUDY_DIRECTOR
affiliation: QUMS
name: Samira Ganbarzade, DDS
role: PRINCIPAL_INVESTIGATOR
References: