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

NCT ID: NCT06742983

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2024-09-20

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

Conditions

Ulcer

Keywords

ulcer; chlorhexidine; Isobutyl cyanoacrylate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Isobutyl cyanoacrylate

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

Group Type: EXPERIMENTAL

Isobutyl cyanoacrylate

Intervention Type: OTHER

Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution

Chlorhexidine 0.2%

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

Group Type: EXPERIMENTAL

Chlorhexidine (0.2%)

Intervention Type: OTHER

Chlorhexidine Digluconate 0.2%

normal saline

will be treated with cotton soaked with normal saline on the ulcer site 5 times per day

Group Type: PLACEBO_COMPARATOR

Normal Saline (0.9% NaCl)

Intervention Type: OTHER

Sodium chloride 0.9%

Interventions

Isobutyl cyanoacrylate

Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution

Intervention Type: OTHER

Chlorhexidine (0.2%)

Chlorhexidine Digluconate 0.2%

Intervention Type: OTHER

Normal Saline (0.9% NaCl)

Sodium chloride 0.9%

Intervention Type: OTHER

Other Intervention Names

periacryl 90 H.V; Elugel 2%; Saline

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

402/2021

Identifier Type: -

Identifier Source: org_study_id