Wound-healingNCT06917599
Low-Level Laser Therapy vs. Saline for Wound Healing After Primary Molar Extraction.
A study testing Low-level laser and Saline Solution (NaCl 0,9%) in people with Wound-healing, run by Cairo University.
Trial summary
To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound-healing
- What is being tested?
- Low-level laser and Saline Solution (NaCl 0,9%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to May 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ● Children aged from 4 to 6 years.
- Children of both genders.
- Medically fit ASA I.
- Children with badly decayed primary molars beyond repair and indicated for extraction.
- Parents acceptance to participate in the study.
- Cooperative children.
- Antibiotics and painkillers have been stopped at least 12 hours prior to the procedure.(Özer et al., 2024)
- Teeth with at least two-thirds of the root.
Who cannot join
- ● Uncooperative children.
- Lack of informed consent by the child patient's parent to be approved ethically.
- Unable to attend follow-up visits to avoid attrition bias by decreasing the number of drop off cases.
- Medical history includes conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers, contraindications to laser therapy, and acute pain.
- Teeth with root lengths less than two-third of the normal root length or those who experienced extensive iatrogenic trauma during tooth extraction.
About this study
Official title: Effect Of Low-Level Laser Therapy Versus Saline On Wound Healing Of Primary Molars Extraction: A Randomized Clinical Trial
To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars
- Conditions
- Wound-healing
- Being tested
- Low-level laser, Saline Solution (NaCl 0,9%)
- Keywords
- laser, therapy, low-level, wound healing, molar, extraction, oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laserDevice
Effect of Low-level laser therapy in wound healing after primary molar extraction
Saline Solution (NaCl 0,9%)Other
Following the extraction, a piece of gauze soaked in normal saline solution (NSS) will be placed over the socket. Both parents and children will be instructed to keep the gauze in place for 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy | Experimental | Effect of Low-level laser therapy in wound healing after primary molar extraction Receives: Device: Low-level laser |
| Saline | Active comparator | Normal saline in wound healing after primary molar extraction Receives: Other: Saline Solution (NaCl 0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of granulation tissue
binary outcome will be recorded by clinical examination as presence or absence of granulation tissue using Landry, Turnbull, Howley Index
Measured: Follow-up day of, 3 days and 7 days after extraction
Secondary outcomes (6)
Assessment of tissue color
Binary (>50% gingiva red, >25% but < 50%gingiva red, <25% gingiva red, All tissue pink) will be recorded by Clinical examination using Landry, Turnbull, and Howley Index
Measured: Follow-up day of, 3 days, and 7 days after extraction
Rate of bleeding on palpation
Measured: Follow-up day of, 3 days, and 7 days after extraction
Presence of suppuration
Clinical examination using Landry, Turnbull, and Howley Index. Unit of measurement is binary (present /absent)
Measured: Follow-up day of, 3 days, and 7 days after extraction
Assessment of gingival margin status
Measured: Follow-up day of, 3 days, and 7 days after extraction
Size of wound
Measured: Follow-up day of, 3 days, and 7 days after extraction
Rate of post operative pain
Score (0-10) will be recorded by Wong-Baker Pain Scale
Measured: Follow-up day of, 3 days, and 7 days after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound-healingStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Mostafa Kamel Sallem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917599
- Sponsor's protocol ID
- LLLT25
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Low-Level Laser Therapy Versus Saline On Wound Healing Of Primary Molars Extraction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06917599
- Acronym / sponsor ID
- LLLT25
- Conditions
- Wound-healing
- Keywords
- laser, therapy, low-level, wound healing, molar, extraction, oral
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 Apr 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.
To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy | Experimental | Device: Low-level laserEffect of Low-level laser therapy in wound healing after primary molar extraction |
| Saline | Active comparator | Other: Saline Solution (NaCl 0,9%)Normal saline in wound healing after primary molar extraction |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- ● Children aged from 4 to 6 years.
Key exclusion criteria (5 listed)
- ● Uncooperative children.
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 laserEffect of Low-level laser therapy in wound healing after primary molar extraction | Device | Low-level laser therapy |
| Saline Solution (NaCl 0,9%)Following the extraction, a piece of gauze soaked in normal saline solution (NSS) will be placed over the socket. Both parents and children will be instructed to keep the gauze in place for 45 minutes | Other | Saline |
Primary outcome
Presence of granulation tissue
Time frame: Follow-up day of, 3 days and 7 days after extraction
binary outcome will be recorded by clinical examination as presence or absence of granulation tissue using Landry, Turnbull, Howley Index
6 secondary outcomes
Assessment of tissue color
Time frame: Follow-up day of, 3 days, and 7 days after extraction
Rate of bleeding on palpation
Time frame: Follow-up day of, 3 days, and 7 days after extraction
Presence of suppuration
Time frame: Follow-up day of, 3 days, and 7 days after extraction
Assessment of gingival margin status
Time frame: Follow-up day of, 3 days, and 7 days after extraction
Size of wound
Time frame: Follow-up day of, 3 days, and 7 days after extraction
Rate of post operative pain
Time frame: Follow-up day of, 3 days, and 7 days after extraction
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 8 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser and Saline Solution (NaCl 0,9%) in people with Wound-healing, run by Cairo University.
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 8 inclusion and 5 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Presence of granulation tissue (time frame: Follow-up day of, 3 days and 7 days after extraction). 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 8 Apr 2025.