Cleft LipPhase 1LLLTNCT06765837
Comparison Between Low Level Laser Therapy and Active Oxygen Releasing Gel on Wound Healing Cleft Lip Patients
A Phase 1 study testing biolase laser and blue m gel in people with Cleft Lip, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
the study was performed on secondary cleft lip scars Read more about this study
- Who is it for?
- Ages 4 to 44 years
- Conditions the study is for
- Cleft Lip
- What is being tested?
- biolase laser and blue m gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2022to 20 Oct 2024
- Phase
- 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 4 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: can be done in any time after six months from the previous surgery if it severely disfiguring or in the preschool stage for children the time of surgery should be based on the severity of deformities
- primary cleft lip repair was done
- secondary lip repair with or without nose correction is indicated
- the patient didn't undergo any surgeries procedures in the last 6 months
Who cannot join
- previously subjected to secondary lip repair surgery.
- syndromic cleft lip patient.
- patient reporting abnormal reaction or scar healing in the previous surgery
- smoking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-Level Diode Laser Versus Active Oxygen Releasing Gel Application on Healing Outcome in Secondary Cleft Lip Correction
the study was performed on secondary cleft lip scars
Read the detailed description
the study aimed at comparing and Evaluation the effect of low-level diode laser and the effect of Active Oxygen releasing gel O3 (Blue-m gel) topical application on healing outcome in secondary cleft lip correction.
- Conditions
- Cleft Lip
- Being tested
- biolase laser, blue m gel
- Keywords
- Low level laser, cleft lip, scars, active oxygen releasing
- Medical subject headings
- Cleft Lip, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biolase laserDevice
after secondary cleft lip surgery to improve wound healing and prevent scar formation laser was used with group I and Gel was applied to Group II
blue m gelDrug
active oxygen releasing gel was used after the secondary cleft lip repair surgery
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Not described Receives: Device: biolase laser |
| active oxygen releasing gel | Experimental | Not described Receives: Drug: blue m gel |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing outcome of the wound is being measured by time
measurements done by ultrasonography repeatedly , before and 1 week after surgery , 3 months after and 6 months after
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start20 Aug 2022
- Primary completion20 Apr 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups underwent secondary repair cleft lip surgeries the first group subjected to low level laser after surgery the second group applied active oxygen releasing topical gel the third was a control group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hager Abd almonem, Faculty of Dental Medicine for Girls
- Investigators
- Mohsena Ahmed, Study director, lecturer of orthodontoics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765837
- Sponsor's protocol ID
- OR SUR-106-1-C
- Acronym
- LLLT
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Diode Laser Versus Active Oxygen Releasing Gel Application on Healing Outcome in Secondary Cleft Lip Correction
- ClinicalTrials.gov ID
- NCT06765837
- Acronym / sponsor ID
- LLLT / OR SUR-106-1-C
- Conditions
- Cleft Lip
- Keywords
- Low level laser, cleft lip, scars, active oxygen releasing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 9 Jan 2025 (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.
the study was performed on secondary cleft lip scars
Detailed description
the study aimed at comparing and Evaluation the effect of low-level diode laser and the effect of Active Oxygen releasing gel O3 (Blue-m gel) topical application on healing outcome in secondary cleft lip correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups underwent secondary repair cleft lip surgeries the first group subjected to low level laser after surgery the second group applied active oxygen releasing topical gel the third was a control group
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Device: biolase laser |
| active oxygen releasing gel | Experimental | Drug: blue m gel |
| control group | No intervention | – |
Who may qualify
- Ages
- 4 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: can be done in any time after six months from the previous surgery if it severely disfiguring or in the preschool stage for children the time of surgery should be based on the severity of deformities
- primary cleft lip repair was done
- secondary lip repair with or without nose correction is indicated
- the patient didn't undergo any surgeries procedures in the last 6 months
Key exclusion criteria (4 listed)
- previously subjected to secondary lip repair surgery.
- syndromic cleft lip patient.
- patient reporting abnormal reaction or scar healing in the previous surgery
- smoking patients
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 |
|---|---|---|
| biolase laserafter secondary cleft lip surgery to improve wound healing and prevent scar formation laser was used with group I and Gel was applied to Group II | Device | Low level laser therapy |
| blue m gelactive oxygen releasing gel was used after the secondary cleft lip repair surgery | Drug | active oxygen releasing gel |
Primary outcome
Healing outcome of the wound is being measured by time
Time frame: 6 months follow up
measurements done by ultrasonography repeatedly , before and 1 week after surgery , 3 months after and 6 months after
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 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mohsena Ahmed study director
lecturer of orthodontoics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing biolase laser and blue m gel in people with Cleft Lip, run by Faculty of Dental Medicine for Girls 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 4 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 9 Jan 2025. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Healing outcome of the wound is being measured by time (time frame: 6 months follow up). 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 9 Jan 2025.