Comparison Between Low Level Laser Therapy and Active Oxy... | NCT06765837

Studies
Comparison Between Low Level Laser Therapy and Active Oxygen Releasing Gel on Wound Healing Cleft Lip Patients

NCT06765837

Sponsor

Faculty of Dental Medicine for Girls

Status

Completed

Last Update Posted

Jan 9, 2025Actual

Enrollment

15Actual

Phase

Phase 1

Conditions

Cleft Lip

Interventions

biolase laser
blue m gel

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2022Actual

Primary Completion Date

Apr 20, 2024Actual

Completion Date

Oct 20, 2024Actual

First Submitted Date

Dec 29, 2024

First Submission Date that Met QC Criteria

Jan 3, 2025

First Posted Date

Jan 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2025

Last Update Posted Date

Jan 9, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hager Abd almonem, master's student at Faculty of dental medicine for girls and dentist at ministry of health, Faculty of Dental Medicine for GirlsPrincipal Investigator

Lead Sponsor

Faculty of Dental Medicine for GirlsOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Low level laser therapy	Experimental	Device: biolase laser
active oxygen releasing gel	Experimental	Drug: blue m gel
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biolase laser	Device	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	Low level laser therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

previously subjected to secondary lip repair surgery.
syndromic cleft lip patient.
patient reporting abnormal reaction or scar healing in the previous surgery
smoking patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

44 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohsena Ahmed	lecturer of orthodontoics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hager Abdelmonem Abdelaziz		Cairo		12345	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip
D002921	Cicatrix

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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