Suez Canal University
Ismailia, Egypt
NCT Number: NCT06742983
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
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Notify Me4 year–8 year
All sexes
Interventional
Not applicable
Ismailia, Egypt
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: -
Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES) will be used for pain assessment
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution
Other names: periacryl 90 H.V
Chlorhexidine Digluconate 0.2%
Other names: Elugel 2%
Sodium chloride 0.9%
Other names: Saline
Time frame: 1st, 5th and 9th days
Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES)
Time frame: 1st, 5th and 9th days.
Photographs of the ulcers will be recorded with a digital camera and Measurement of ulcer size by using a periodontal probe.
Suez Canal University
Other
Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children: A Clinical and Experimental Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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