Aphthous StomatitisPhase 2NCT01210014
Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study
A Phase 2 study testing zinc sulphate 220mg/day in one dosage in people with Aphthous Stomatitis, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- zinc sulphate 220mg/day in one dosage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteIran
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Qazvin university of medical sciences
Qazvin, Qazvin Province, 3415759811
About this study
Official title: Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis
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.
Read the 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.
- Conditions
- Aphthous Stomatitis
- Being tested
- zinc sulphate 220mg/day in one dosage, placebo: one dosage
- Keywords
- Recurrent aphthous stomatitis, treatment, zinc sulphate
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulphate 220mg/day in one dosageDrug
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.
placebo: one dosageDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Patients with Recurrent aphthous stomatitis Receives: Drug: placebo: one dosage |
| B | Active comparator | Patients with Recurrent aphthous stomatitis Receives: Drug: zinc sulphate 220mg/day in one dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvment of Recurrent Aphthous Ulcerations
To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale
Measured: 5 months
Secondary outcomes (2)
Relief sign &symptom
Measured: 5 months
relief clinical features
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Kataun Borhanmojabi, DDS,MSC, Study chair, QUMSTouba Karagah, DDS, Principal investigator, QUMSReza Mortazavi, PHD, Study director, QUMSSamira Ganbarzade, DDS, Principal investigator, QUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210014
- Sponsor's protocol ID
- QUMS320
- Status last verified
- Sep 2010
- First submitted
- 2 Sep 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Sulphate in Treatment of Recurrent Aphthous Stomatitis
- ClinicalTrials.gov ID
- NCT01210014
- Acronym / sponsor ID
- QUMS320
- Conditions
- Aphthous Stomatitis
- Keywords
- Recurrent aphthous stomatitis, treatment, zinc sulphate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: placebo: one dosagePatients with Recurrent aphthous stomatitis |
| B | Active comparator | Drug: zinc sulphate 220mg/day in one dosagePatients with Recurrent aphthous stomatitis |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc sulphate 220mg/day in one dosagepatients 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. | Drug | B |
| placebo: one dosagepatients 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. | Drug | A |
Primary outcome
improvment of Recurrent Aphthous Ulcerations
Time frame: 5 months
To assess the improvment of Recurrent Aphthous Ulceration according to Vissual Analoge Scale
2 secondary outcomes
Relief sign &symptom
Time frame: 5 months
relief clinical features
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kataun Borhanmojabi, DDS,MSC study chair
QUMS
Touba Karagah, DDS principal investigator
QUMS
Reza Mortazavi, PHD study director
QUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zinc sulphate 220mg/day in one dosage in people with Aphthous Stomatitis, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvment of Recurrent Aphthous Ulcerations (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.