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

NCT01210014 | Completed Phase 2 DMC

• 1 other identifier: QUMS320
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphthous Stomatitis

Keywords

Recurrent aphthous stomatitis; treatment; zinc sulphate

Outcome Measures

Primary Outcomes (1)

• improvment of Recurrent Aphthous Ulcerations

  To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale

  5 months

Secondary Outcomes (2)

• Relief sign &symptom

  5 months

• relief clinical features

  5 months

Study Arms (2)

A

PLACEBO COMPARATOR

Patients with Recurrent aphthous stomatitis

Drug: placebo: one dosage

B

ACTIVE COMPARATOR

Patients with Recurrent aphthous stomatitis

Drug: zinc sulphate 220mg/day in one dosage

Interventions

zinc sulphate 220mg/day in one dosage 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

placebo: one dosage 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.

A

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin university of medical sciences

Qazvin, Qazvin Province, 3415759811, Iran

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Kataun Borhanmojabi, DDS,MSC

  QUMS

  STUDY CHAIR

• Touba Karagah, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

• Reza Mortazavi, PHD

  QUMS

  STUDY DIRECTOR

• Samira Ganbarzade, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 28, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 28, 2010

Record last verified: 2010-09

Locations

IR (1)