Clinical trial NCT06742983: Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children
Official title: Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children: A Clinical and Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer
Keywords: ulcer
chlorhexidine
Isobutyl cyanoacrylate
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

  * Children will be examined before treatment to assess pain by using Children's International Mucositis Evaluation Scale (ChIMES) and measure ulcer size by periodontal probe. Then apply different treatments of each group
  * All patients in both groups will be instructed to avoid eating or drinking for at least half an hour after oral administration of the oral gel.
  * All patients can be given oral analgesics (paracetamol) if needed to decrease pain severity.
  * The size of the ulcers, change in pain severity will be assessed on the 1st, 5th and 9th days after using isobutyl cyanoacrylate high viscous solution and chlorhexidine (0.2%) gel.

Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES) will be used for pain assessment

1. Photographs of the ulcers will be recorded with a digital camera at 1st, 5th and 9th days.
2. Measurement of ulcer size by using a periodontal probe

Eligibility criteria: 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

Primary outcomes:
measure: pain assessment
timeFrame: 1st, 5th and 9th days
measure: Measurement of ulcer size
timeFrame: 1st, 5th and 9th days.
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References: