Improving Healing in Children After Tooth Extraction Usin... | NCT07205640

Studies
Improving Healing in Children After Tooth Extraction Using Laser Therapy or Hyaluronic Acid

NCT07205640

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Oct 3, 2025Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Mesh
Healthy Volunteer
Low Level Laser Therapy
Hyaluronic Acid Gel for Preservation the Extraction Socket
Extraction Socket Healing
Badly Decayed Molars
Tooth Extraction Site Healing

Interventions

Low-Level Laser Therapy
Hyaluronic Acid (HA)

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

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Aug 8, 2025

First Submission Date that Met QC Criteria

Sep 25, 2025

First Posted Date

Oct 3, 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

Sep 25, 2025

Last Update Posted Date

Oct 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mona Ali Abd Elhafiz Ali, Bachelor Degree in Oral and Dental Medicine, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Tooth extraction may be an unpleasant and painful experience for children, Post-extraction wound healing. Low-level laser therapy (LLLT) is a widely used adjuvant treatment for wound healing, resulting in both an increase in cell number and an increase in cell metabolism. HA it is an important component of the extracellular matrix and a constituent of the neural, connective, and epithelial tissues.

Detailed Description

Tooth extraction may be an unpleasant and painful experience for children. Pain felt during dental treatment, especially tooth extraction, is the most common complication. Pain management during and after tooth extraction is part of behavioral guidance, especially in pediatric patients.

Post-extraction wound healing and pain perception are related to hostrelated factors such as the patient's immune system, the use of painkillers and antibiotics, the presence of infection in the region, and the atraumatic nature of the procedure. Low-level laser therapy (LLLT) is a widely used adjuvant treatment for wound healing. It is based on the idea that exposure to a specific wavelength can alter cellular behavior, resulting in both an increase in cell number and an increase in cell metabolism. Aside from not having any negative effects, LLLT is an a thermic, photobiological, and nondestructive therapy approach.

HA it is an important component of the extracellular matrix and a constituent of the neural, connective, and epithelial tissues. Among the many biological effects of HA are its functions in cell differentiation, wound healing, inflammation, embryological development, and viscoelasticity.

Conditions Module

Conditions

Mesh
Healthy Volunteer
Low Level Laser Therapy
Hyaluronic Acid Gel for Preservation the Extraction Socket
Extraction Socket Healing
Badly Decayed Molars
Tooth Extraction Site Healing

Keywords

hyaluronic acid
low level laser therapy
tooth extraction

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-Level Laser Therapy (LLLT)	Experimental	Participants in this arm will receive low-level laser therapy (LLLT) immediately after extraction of the first permanent molar.	Device: Low-Level Laser Therapy
Hyaluronic Acid (HA)	Experimental	Participants in this arm will receive hyaluronic acid (HA) immediately after extraction of the first permanent molar.	Drug: Hyaluronic Acid (HA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-Level Laser Therapy	Device	A 980 nm diode laser will be applied immediately after extraction of the first permanent molar. The laser will be used in continuous mode at 0.5 W, with a total energy of 300 J, applied for 60 seconds at three points around the extraction socket.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound size	Wound size unit of measure : mm (millimeters) (mesiodistal and buccolingual dimension of each socket).	7 days

Secondary Outcomes

Measure	Description	Time Frame
Tissue Color Changes	Gingival color assessed using the Landry, Turnbull, and Howley Index (normal vs inflamed). Unit of Measure: Binary (normal / inflamed)	Day 0, Day 3, and Day 7 post-extraction.
Bleeding Upon Palpation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged from six to ten years.
Children of both genders.
Children with badly decayed first permanent molar beyond repair and indicated for extraction.
Parents acceptance to participate in the study.

Exclusion Criteria:

Medically compromised children.
Uncooperative children.
Children who will not attend the follow up visits

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mona Ali Abd Elhafiz, BDS	Contact	+201000323801		info@cu.edu.eg
Mona Ali AbdelHafiz, BDS	Contact	+201000323801		mona.ali@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Mona Ali Abd Elhafiz, BDS	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty Of Oral & Dental Medicine - Cairo University		Giza	EL Menial	12613	Egypt

References Module

Citations

Not provided

ID	Term
D028022	Low-Level Light Therapy
D006820	Hyaluronic Acid

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates