UlcerNCT06742983
Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children
A study testing Isobutyl cyanoacrylate, Chlorhexidine (0.2%) and Normal Saline (0.9% NaCl) in people with Ulcer, run by Suez Canal University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Ulcer
- What is being tested?
- Isobutyl cyanoacrylate, Chlorhexidine (0.2%) and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Aug 2023to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children: A Clinical and Experimental Study
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
Read the 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
- 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
- Conditions
- Ulcer
- Being tested
- Isobutyl cyanoacrylate, Chlorhexidine (0.2%), Normal Saline (0.9% NaCl)
- Keywords
- ulcer, chlorhexidine, Isobutyl cyanoacrylate
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isobutyl cyanoacrylateOther
Also called periacryl 90 H.V
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%)Other
Also called Elugel 2%
Chlorhexidine Digluconate 0.2%
Normal Saline (0.9% NaCl)Other
Also called Saline
Sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment
Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES)
Measured: 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.
Measured: 1st, 5th and 9th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start4 Aug 2023
- Primary completion4 Aug 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcerStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742983
- Sponsor's protocol ID
- 402/2021
- Status last verified
- Sep 2024
- First submitted
- 15 Dec 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children: A Clinical and Experimental Study
- ClinicalTrials.gov ID
- NCT06742983
- Acronym / sponsor ID
- 402/2021
- Conditions
- Ulcer
- Keywords
- ulcer, chlorhexidine, Isobutyl cyanoacrylate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 4 Aug 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isobutyl cyanoacrylate | Experimental | Other: Isobutyl cyanoacrylateThin 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 |
| Chlorhexidine 0.2% | Experimental | Other: 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 |
| normal saline | Placebo comparator | Other: Normal Saline (0.9% NaCl)will be treated with cotton soaked with normal saline on the ulcer site 5 times per day |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isobutyl cyanoacrylateAlso: periacryl 90 H.VThin layers of a high viscosity isobutyl cyanoacrylate high viscous solution Thin layers of a high viscosity isobutyl cyanoacrylate high viscous solution | Other | Isobutyl cyanoacrylate |
| Chlorhexidine (0.2%)Also: Elugel 2%Chlorhexidine Digluconate 0.2% | Other | Chlorhexidine 0.2% |
| Normal Saline (0.9% NaCl)Also: SalineSodium chloride 0.9% | Other | normal saline |
Primary outcome
pain assessment
Time frame: 1st, 5th and 9th days
Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isobutyl cyanoacrylate, Chlorhexidine (0.2%) and Normal Saline (0.9% NaCl) in people with Ulcer, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessment (time frame: 1st, 5th and 9th days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.