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

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: Not yet recruiting
• Conditions: Wound-healing
• Intervention / Treatment: Device: Low-level laser; Other: Saline Solution (NaCl 0,9%)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Presence of granulation tissue	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

Outcome Measure	Measure Description	Time Frame
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	Follow-up day of, 3 days, and 7 days after extraction
Rate of bleeding on palpation		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)	Follow-up day of, 3 days, and 7 days after extraction
Assessment of gingival margin status		Follow-up day of, 3 days, and 7 days after extraction
Size of wound		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	Follow-up day of, 3 days, and 7 days after extraction

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Estimated): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: oral; wound healing; laser; therapy; molar; extraction; low-level
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID 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