An interventional study of Isobutyl cyanoacrylate and Chlorhexidine (0.2%) in Ulcer, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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 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
2,021 studies on the registry are indexed under Ulcer; 216 are open to participants now.
This study's enrollment of 30 is below the median of 68 across 1,615 interventional studies indexed under Ulcer.
Browse Ulcer studies →Suez Canal University is the lead sponsor of 157 studies on the registry; 37 are open to participants now.
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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
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
Other: Isobutyl cyanoacrylate
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
Other: Chlorhexidine (0.2%)
will be treated with cotton soaked with normal saline on the ulcer site 5 times per day
Other: Normal Saline (0.9% NaCl)
Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution
Also known as: periacryl 90 H.V
Chlorhexidine Digluconate 0.2%
Also known as: Elugel 2%
Sodium chloride 0.9%
Also known as: Saline
pain assessment
Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES)
Time frame: 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.
Time frame: 1st, 5th and 9th days.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Suez Canal University