MeshLLLT vs HANCT07205640
Improving Healing in Children After Tooth Extraction Using Laser Therapy or Hyaluronic Acid
A study testing Low-Level Laser Therapy and Hyaluronic Acid (HA) in people with Mesh and Healthy Volunteer, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Mesh, Healthy Volunteer, Low Level Laser Therapy
- What is being tested?
- Low-Level Laser Therapy and Hyaluronic Acid (HA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Medically compromised children.
- Uncooperative children.
- Children who will not attend the follow up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty Of Oral & Dental Medicine - Cairo University
Giza, EL Menial, 12613
About this study
Official title: Effect of Low-Level Laser Therapy Versus Hyaluronic Acid on Wound Healing After First Permanent Molar Extraction in Children.
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.
Read the 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
- Mesh, Healthy Volunteer, Low Level Laser Therapy, Hyaluronic Acid Gel for Preservation the Extraction Socket, Extraction Socket Healing, Badly Decayed Molars
- Being tested
- Low-Level Laser Therapy, Hyaluronic Acid (HA)
- Keywords
- hyaluronic acid, low level laser therapy, tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyDevice
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.
Hyaluronic Acid (HA)Drug
Hyaluronic acid gel will be applied directly into the extraction socket immediately after tooth removal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound size
Wound size unit of measure : mm (millimeters) (mesiodistal and buccolingual dimension of each socket).
Measured: 7 days
Secondary outcomes (4)
Tissue Color Changes
Gingival color assessed using the Landry, Turnbull, and Howley Index (normal vs inflamed).
Unit of Measure: Binary (normal / inflamed)
Measured: Day 0, Day 3, and Day 7 post-extraction.
Bleeding Upon Palpation
Presence or absence of bleeding when palpating the extraction site.
Unit of Measure: Binary (yes / no)
Measured: Day 0, Day 3, and Day 7 post-extraction.
Pus Presence
Presence or absence of pus at the extraction site.
Unit of Measure: Binary (yes / no)
Measured: Day 0, Day 3, and Day 7 post-extraction.
Pain Level During Application
Pain assessed using Wong-Baker Faces Pain Rating Scale (0 = no pain, 10 = worst pain).
(0 = no pain, 10 = worst pain). Higher scores indicate worse outcomes.
Measured: Immediately after intervention (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeshStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ali Abd Elhafiz Ali, Cairo University
- Investigators
- Mona Ali Abd Elhafiz, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205640
- Sponsor's protocol ID
- LLLTvsHA-2025
- Acronym
- LLLT vs HA
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Laser Therapy Versus Hyaluronic Acid on Wound Healing After First Permanent Molar Extraction in Children.
- ClinicalTrials.gov ID
- NCT07205640
- Acronym / sponsor ID
- LLLT vs HA / LLLTvsHA-2025
- Conditions
- Mesh, Healthy Volunteer, Low Level Laser Therapy, Hyaluronic Acid Gel for Preservation the Extraction Socket, Extraction Socket Healing, Badly Decayed Molars
- Keywords
- hyaluronic acid, low level laser therapy, tooth extraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy (LLLT) | Experimental | Device: Low-Level Laser TherapyParticipants in this arm will receive low-level laser therapy (LLLT) immediately after extraction of the first permanent molar. |
| Hyaluronic Acid (HA) | Experimental | Drug: Hyaluronic Acid (HA)Participants in this arm will receive hyaluronic acid (HA) immediately after extraction of the first permanent molar. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Medically compromised children.
- Uncooperative children.
- Children who will not attend the follow up visits
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 |
|---|---|---|
| Low-Level Laser TherapyA 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. | Device | Low-Level Laser Therapy (LLLT) |
| Hyaluronic Acid (HA)Hyaluronic acid gel will be applied directly into the extraction socket immediately after tooth removal. | Drug | Hyaluronic Acid (HA) |
Primary outcome
wound size
Time frame: 7 days
Wound size unit of measure : mm (millimeters) (mesiodistal and buccolingual dimension of each socket).
4 secondary outcomes
Tissue Color Changes
Time frame: Day 0, Day 3, and Day 7 post-extraction.
Bleeding Upon Palpation
Time frame: Day 0, Day 3, and Day 7 post-extraction.
Pus Presence
Time frame: Day 0, Day 3, and Day 7 post-extraction.
Pain Level During Application
Time frame: Immediately after intervention (Day 0).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background reference on low-level laser therapy and wound healing in dentistry.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Mona Ali Abd Elhafiz, BDS principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy and Hyaluronic Acid (HA) in people with Mesh and Healthy Volunteer, run by Cairo 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 3 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Ali Abd Elhafiz, BDS (+201000323801, info@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound size (time frame: 7 days). 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 3 Oct 2025.