Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will be Included in This StudyEarly Phase 1NCT06705920
Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization
A Early Phase 1 study testing topical oxygen gel in people with Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will be Included in This Study, run by Ain Shams University at 1 site in Egypt.
Trial summary
To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will be Included in This Study
- What is being tested?
- topical oxygen gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2025to 4 Aug 2026
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients in a healthy systemic condition who required comprehensive dental treatment
- Both genders with age group > 18 years old
- Patients should approve to deliver a signature to a written consent after study nature explanation.
Who cannot join
- Patients with severe smoking habits >10 cig \ day
- Pregnant females, decisional impaired individuals and handicapped patients
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures
- Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization : Randomized Controlled Clinical Trial
To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures
Read the detailed description
All the patients who will agree to participate in the study and who will sign the informed consent forms. Computer-generated randomization will be used to randomly divide the surgical sites into two groups. Control group: will receive no treatment. Study group: will receive active oxygen gel around suture. Patients scheduled for any oral surgical flap procedure that require suturing will be included in this study. After flap approximation, the surgical site will be sutured using 5-0 braided sutures. In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab, three times a day after brushing their teeth. Also, patients will be given instructions regarding their post-surgical care.
- Being tested
- topical oxygen gel
- Keywords
- active oxygen, sutures, flap, microbiology, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical oxygen gelDrug
In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | patient who will undergo intraoral surgical procedures , will have his wound sutured without any addtives |
| test | Active comparator | patient who will undergo intraoral surgical procedures , will have his wound sutured with the addition of blue m gel twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological assessment
The collected samples of suture thread will be immersed in phosphate-buffered saline solution (PBS) immediately after their removal and This sample will be subsequently sent to the microbiology laboratory of the Faculty of Pharmacy of the British university in Egypt. The samples will be shaken vigorously for two minutes to separate the bacteria from the suture thread, and to obtain a homogeneous suspension. serial dilutions in saline will be subsequently prepared. 50 microliters of each dilution will be plated in Petri dishes containing different culture media.The blood agar, mannitol agar, MacConkey agar, and Sabouraud agar plates will be aerobically incubated at 37 °C for 24-48 hours. After incubation, the colony forming units (CFUs) will be counted and the total number of CFUs per milliliter of initial solution will be calculated
Measured: 2 weeks
Secondary outcomes (1)
Post operative wound healing.
Wound healing will be recorded in the 1st and 2 weeks postoperatively through Landry Wound Healing Index (LWHI) which evaluates the surgical site based on tissue color, response to touch, the marginality of the incision line, and extent of the area. The rating is from 1 = very poor to 5 = excellent.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start12 Jan 2025
- Primary completion15 Jul 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will be Included in This StudyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- British University In Egypt
- Responsible party
- Principal investigator, ahmed hamdy mahmoud, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705920
- Sponsor's protocol ID
- 24-042
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization : Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06705920
- Acronym / sponsor ID
- 24-042
- Keywords
- active oxygen, sutures, flap, microbiology, wound healing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- British University In Egypt
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 26 Nov 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.
To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures
Detailed description
All the patients who will agree to participate in the study and who will sign the informed consent forms. Computer-generated randomization will be used to randomly divide the surgical sites into two groups. Control group: will receive no treatment. Study group: will receive active oxygen gel around suture. Patients scheduled for any oral surgical flap procedure that require suturing will be included in this study. After flap approximation, the surgical site will be sutured using 5-0 braided sutures. In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab, three times a day after brushing their teeth. Also, patients will be given instructions regarding their post-surgical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patient who will undergo intraoral surgical procedures , will have his wound sutured without any addtives |
| test | Active comparator | –patient who will undergo intraoral surgical procedures , will have his wound sutured with the addition of blue m gel twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients in a healthy systemic condition who required comprehensive dental treatment
- Both genders with age group > 18 years old
- Patients should approve to deliver a signature to a written consent after study nature explanation.
Key exclusion criteria (4 listed)
- Patients with severe smoking habits >10 cig \ day
- Pregnant females, decisional impaired individuals and handicapped patients
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures
- Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
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 |
|---|---|---|
| topical oxygen gelIn the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab | Drug | – |
Primary outcome
Microbiological assessment
Time frame: 2 weeks
The collected samples of suture thread will be immersed in phosphate-buffered saline solution (PBS) immediately after their removal and This sample will be subsequently sent to the microbiology laboratory of the Faculty of Pharmacy of the British university in Egypt. The samples will be shaken vigorously for two minutes to separate the bacteria from the suture thread, and to obtain a homogeneous suspension. serial dilutions in saline will be subsequently prepared. 50 microliters of each dilution will be plated in Petri dishes containing different culture media.The blood agar, mannitol agar, MacConkey agar, and Sabouraud agar plates will be aerobically incubated at 37 °C for 24-48 hours. After incubation, the colony forming units (CFUs) will be counted and the total number of CFUs per milliliter of initial solution will be calculated
1 secondary outcome
Post operative wound healing.
Time frame: 2 weeks
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes
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 Early Phase 1 study testing topical oxygen gel in people with Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will be Included in This Study, run by Ain Shams 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 4 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 13 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Microbiological assessment (time frame: 2 weeks). 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 13 Aug 2026.