Aphthous StomatitisPhase 2NCT01293968
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
A Phase 2 study testing Ibuprofen, Diphenhydramine and Aluminium MgS and Diphenhydramine and Aluminium MgS in people with Aphthous Stomatitis, run by Qazvin University Of Medical Sciences at 2 sites in Iran.
Trial summary
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS) 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?
- Ibuprofen, Diphenhydramine and Aluminium MgS and Diphenhydramine and Aluminium MgS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesIran
- Study dates
- Nov 2010to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- possessing at least one painful aphthous ulcer in the last 3 days
- older than 10 years of age
Who cannot join
- systemic disease or specific syndrome (such as Behcet's)
- pregnancy
- breastfeeding
- allergy to NSAIDs
- history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders
- consumption of anti-inflammatory medications in the last 24 hours
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Dental faculty of Qazvin University of Medical Sciences
Qazvin, Qazvin Province
Qazvin University of Medical sciences
Qazvin, Qazvin Province
About this study
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)
Read the detailed description
Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.
The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.
This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.
All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).
- Conditions
- Aphthous Stomatitis
- Being tested
- Ibuprofen, Diphenhydramine and Aluminium MgS, Diphenhydramine and Aluminium MgS
- Keywords
- Aphthous Stomatitis, Ibuprofen, treatment efficacy
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen, Diphenhydramine and Aluminium MgSDrug
3 times daily for 3 days
Diphenhydramine and Aluminium MgSDrug
3 times daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg | Experimental | Not described Receives: Drug: Ibuprofen, Diphenhydramine and Aluminium MgS |
| 100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg | Active comparator | Not described Receives: Drug: Diphenhydramine and Aluminium MgS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution
Measured: four days after the start of the study
Secondary outcomes (1)
The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation
pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed
Measured: 4 days after the solution consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pantea Nazeman, Qazvin University Of Medical Sciences
- Investigators
- Katayun Borhanmojabi, D.D.S,M.S, Study chair, QUMSKatayun Borhanmojabi, D.D.S,M.S, Study director, QUMSMarjan Nasiri asl, PhD, Study director, QUMSFaeze Mirmiran, D.D.S, Principal investigator, QUMSPantea Nazeman, student, Principal investigator, QUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293968
- Sponsor's protocol ID
- qums353
- Status last verified
- May 2012
- First submitted
- 10 Feb 2011
- Last updated
- 20 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
- ClinicalTrials.gov ID
- NCT01293968
- Acronym / sponsor ID
- qums353
- Conditions
- Aphthous Stomatitis
- Keywords
- Aphthous Stomatitis, Ibuprofen, treatment efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)
Detailed description
Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.
The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.
This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.
All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg | Experimental | Drug: Ibuprofen, Diphenhydramine and Aluminium MgS |
| 100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg | Active comparator | Drug: Diphenhydramine and Aluminium MgS |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- possessing at least one painful aphthous ulcer in the last 3 days
- older than 10 years of age
Key exclusion criteria (6 listed)
- systemic disease or specific syndrome (such as Behcet's)
- pregnancy
- breastfeeding
- allergy to NSAIDs
- history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders
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 |
|---|---|---|
| Ibuprofen, Diphenhydramine and Aluminium MgS3 times daily for 3 days | Drug | 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg |
| Diphenhydramine and Aluminium MgS3 times daily for 3 days | Drug | 100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg |
Primary outcome
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
Time frame: four days after the start of the study
pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution
1 secondary outcome
The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation
Time frame: 4 days after the solution consumption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katayun Borhanmojabi, D.D.S,M.S study chair
QUMS
Katayun Borhanmojabi, D.D.S,M.S study director
QUMS
Marjan Nasiri asl, PhD study director
QUMS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen, Diphenhydramine and Aluminium MgS and Diphenhydramine and Aluminium MgS in people with Aphthous Stomatitis, run by Qazvin University Of Medical Sciences at 2 sites 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 2 inclusion and 6 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 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation (time frame: four days after the start of the study). 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 20 Jun 2012.