Evaluation of the effect of a synthetic mouthwash(doxepin, chitosan) on the oral ulcers pain and size in comparison with common analgesic mouthwash (Diphenhydramine, AlMgS, lidocaine gel)

This study is aimed to introduce new composition (chitosan, doxepin) for oral pain relief and size of lesions caused by different etiologies

Patients with oral ulcers will be enrolled in two groups by block randomization. In case group 10 patients will use this formulated mouthwash (chitosan, doxepin) as an analgesic agent. In control group 10 patients will use common prescribed mouthwash (Diphenhydramine 12.5 mg/5ml susp Aluminum Mgs and lidocaine gel 2%) . After gargling these analgesics agent for 5 minute, The VAS of patients will be measured in 5, 15, 30 minute and 1 hour intervals. Both participants in case and control group will use the mouthwash three times a day until they suffer from pain. The VAS will be measured also in day 1,2,3. This study is second phase of clinical trial.

This clinical trial will be done on patients that will be referred to oral and maxillofacial Department of Shiraz Dental School during 2017-2018. A mouthwash will be prescribed for the patients with informed consent . The investigator who evaluate the level of pain and the data analyzer also are blind to the type of prescribed mouthwash.etiologies

Inclusion criteria:The patient who has painful oral lesion (new case of oral lesions without receiving any treatment) who are not pregnant who are not diabetic The patient with no other inflammatory disease Exclusion criteria: The patients who have used any analgesic agents (systemic or local) since 2 days ago The patients who have used anti-inflammatory medication such as corticosteroid since 2 weeks ago

The participants who will be enrolled in case group (10 patients) will use this formulated mouthwash (chitosan, doxepin) as an analgesic agent. After gargling these analgesics agent for 5 minute, VAS of patients will be measured in 5, 15, 30 minute and 1 hour intervals. The participants will use this mouthwash three times a day until they suffer from pain.The VAS and size of patients' lesions will be measured after gargling also in day 1,2,3. Any probable side effect of this mouthwash will be evaluated by one week follow up of patients. In control group patients will use common prescribed mouthwash (Diphenhydramine 12.5 mg/5ml susp Aluminum Mgs and lidocaine gel 2%). After gargling these analgesics agent for 5 minute, VAS of patients will be measured in 5, 15, 30 minute and 1 hour intervals. The participants will use their mouthwash three times a day until they suffer from pain and their VAS and size of patients' lesions will be measured after each gargling also in day 1,2,3. Any probable side effect of this mouthwash will be evaluated by one week follow up of patients

VAS of patients will be evaluated after gargeling; size of oral ulcers

block randomization individual Unit of randomization Tools used in randomization is table of random number

The investigator who evaluate the level of pain and the data analyser also are blind to the type of prescribed mouthwash.

specific participant data sets are to be shared (e.g., all collected deidentified IPD, IPD collected for the primary outcome mean and statistical analysis

starting 1year after publication

The researcher who will email the responsible individual in this study and send the request

The researcher who will email the responsible individual in this study and this person should be an academic member of medical universities.

The data will be obtainable by email.

The researcher who will email the responsible individual in this study and send the request.