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30 children with traumatic oral ulcer that will be divided into equal three groups. Group A (Isobutyl cyanoacrylate) includes children will be treated with isobutyl cyanoacrylate high viscous solution only once during the treatment episode, group B (control positive) includes children will be treated chlorohexidine gel (0.2%) twice daily and group C (control negative) includes children will be treated with normal saline five times per day. Clinical follow up will be done by assessment of pain perception, photographs of the ulcer will be recorded by using digital camera and measurement of ulcer size in the 1st ,5th and 9th days after treatment
Thirty children will be randomly and equally allocated into three groups, by throwing a dice (1&4 for group A, 2&5 for group B and 3&6 for group C). 10 for each group as follows: -
Group A (Isobutyl cyanoacrylate): 10 children will be treated with isobutyl cyanoacrylate high viscous solution will be applied on the ulcer site.
Group B (control positive): 10 children will be treated with chlorhexidine (0.2%) gel twice daily for 9 days.
Group C (control negative): 10 children will be treated with normal saline will be applied on the ulcer site 5 times per day.
Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES) will be used for pain assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isobutyl cyanoacrylate | Experimental | Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution (periacryl 90 H.V) tissue adhesive will be applied on the ulcer site by using a pipette then rinsed with saline by using another pipette at least three times with an interval of at least 30 seconds once during the treatment episode to allow for complete polymerization, until achieving hemostasis |
|
| Chlorhexidine 0.2% | Experimental | Application of chlorhexidine 0.2% (Elugel 2%) on finger tip then spread it on the ulcer site and gentle massaging twice daily for 9 days |
|
| normal saline | Placebo Comparator | will be treated with cotton soaked with normal saline on the ulcer site 5 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isobutyl cyanoacrylate | Other | Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution |
| Measure | Description | Time Frame |
|---|---|---|
| pain assessment | Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES) | 1st, 5th and 9th days |
| Measurement of ulcer size | Photographs of the ulcers will be recorded with a digital camera and Measurement of ulcer size by using a periodontal probe. | 1st, 5th and 9th days. |
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Inclusion Criteria:
Apparently healthy cooperative children free from any systemic diseases that may predispose oral ulceration.
Development of pain/ulceration in the oral mucosa, surrounded by light red areola less than 1 cm. diameter.
Child with good oral hygiene. Parents willing to participate in the study and have a good likelihood of recall availability
Exclusion Criteria:
Taking of drugs that may influence the pattern of oral ulceration Oral ulcerations with unknown etiology that are not traumatic in nature. Allergic or who have suffered adverse reactions to isobutyl cyanoacrylate gel or chlorhexidine gel
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University | Ismailia | Egypt |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002015 | Bucrylate |
| D002710 | Chlorhexidine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003487 | Cyanoacrylates |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| Chlorhexidine (0.2%) | Other | Chlorhexidine Digluconate 0.2% |
|
|
| Normal Saline (0.9% NaCl) | Other | Sodium chloride 0.9% |
|
|
| D009930 |
| Organic Chemicals |
| D009570 | Nitriles |
| D004659 | Enbucrilate |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |