Low-Level Laser Therapy vs. Saline for Wound Healing After Primary Molar Extraction.

April 2, 2025 updated by: Hadeer Mostafa Kamel Sallem, Cairo University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ● 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.

Exclusion Criteria:

  • ● 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-level laser therapy
Effect of Low-level laser therapy in wound healing after primary molar extraction
Device: Low-level laser
Effect of Low-level laser therapy in wound healing after primary molar extraction
Active Comparator: Saline
Normal saline in wound healing after primary molar extraction
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Follow-up day of, 3 days and 7 days after extraction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of tissue color
Time Frame: Follow-up day of, 3 days, and 7 days after extraction
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
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
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
Clinical examination using Landry, Turnbull, and Howley Index. Unit of measurement is binary (present /absent)
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
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
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
Score (0-10) will be recorded by Wong-Baker Pain Scale
Follow-up day of, 3 days, and 7 days after extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LLLT25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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