NCT07205640

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

August 8, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

August 8, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

hyaluronic acidlow level laser therapytooth extraction

Outcome Measures

Primary Outcomes (1)

  • wound size

    Wound size unit of measure : mm (millimeters) (mesiodistal and buccolingual dimension of each socket).

    7 days

Secondary Outcomes (4)

  • Tissue Color Changes

    Day 0, Day 3, and Day 7 post-extraction.

  • Bleeding Upon Palpation

    Day 0, Day 3, and Day 7 post-extraction.

  • Pus Presence

    Day 0, Day 3, and Day 7 post-extraction.

  • Pain Level During Application

    Immediately after intervention (Day 0).

Study Arms (2)

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

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.

Low-Level Laser Therapy (LLLT)

Hyaluronic acid gel will be applied directly into the extraction socket immediately after tooth removal.

Hyaluronic Acid (HA)

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Oral & Dental Medicine - Cairo University

Giza, EL Menial, 12613, Egypt

Location

Related Links

MeSH Terms

Interventions

Low-Level Light TherapyHyaluronic Acid

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Mona Ali Abd Elhafiz, BDS

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Ali Abd Elhafiz, BDS

CONTACT

Mona Ali AbdelHafiz, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
outcome assessors and statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor Degree in Oral and Dental Medicine

Study Record Dates

First Submitted

August 8, 2025

First Posted

October 3, 2025

Study Start

December 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

This is an academic master's degree study. The individual participant data (IPD) will not be shared outside the study team to ensure patient confidentiality. Only aggregate results will be published.

Locations