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Completed

NCT Number: NCT06742983

Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children

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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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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

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

Who can participate

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

Treatment and study plan

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

Other names: periacryl 90 H.V

Chlorhexidine (0.2%)

Other

Chlorhexidine Digluconate 0.2%

Other names: Elugel 2%

Normal Saline (0.9% NaCl)

Other

Sodium chloride 0.9%

Other names: Saline

Primary outcomes

  1. pain assessment

    Time frame: 1st, 5th and 9th days

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

  2. Measurement of ulcer size

    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.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children: A Clinical and Experimental Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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