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

NCT06742983 | Completed

• 1 other identifier: 402/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcer

Keywords

ulcer; chlorhexidine; Isobutyl cyanoacrylate

Outcome Measures

Primary Outcomes (2)

• pain assessment

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

  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.

  1st, 5th and 9th days.

Study Arms (3)

Isobutyl cyanoacrylate

EXPERIMENTAL

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

Chlorhexidine 0.2%

EXPERIMENTAL

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%)

normal saline

PLACEBO COMPARATOR

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

Other: Normal Saline (0.9% NaCl)

Interventions

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

Also known as: periacryl 90 H.V

Isobutyl cyanoacrylate

Chlorhexidine (0.2%) OTHER

Chlorhexidine Digluconate 0.2%

Also known as: Elugel 2%

Chlorhexidine 0.2%

Normal Saline (0.9% NaCl) OTHER

Sodium chloride 0.9%

Also known as: Saline

normal saline

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Ulcer

Interventions

Bucrylate; Chlorhexidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyanoacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Enbucrilate; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: August 4, 2023
• Primary Completion: August 4, 2024
• Study Completion: September 20, 2024
• Last Updated: January 22, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)