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

NCT06917599 | Not Yet Recruiting

• 1 other identifier: LLLT25
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars

Conditions

Wound-healing

Keywords

laser; therapy; low-level; wound healing; molar; extraction; oral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of tissue color

  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

  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

Study Arms (2)

Low-level laser therapy

EXPERIMENTAL

Effect of Low-level laser therapy in wound healing after primary molar extraction

Device: Low-level laser

Saline

ACTIVE COMPARATOR

Normal saline in wound healing after primary molar extraction

Other: Saline Solution (NaCl 0,9%)

Interventions

Low-level laser DEVICE

Effect of Low-level laser therapy in wound healing after primary molar extraction

Low-level laser therapy

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

Saline

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ● 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.

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Low-Level Light Therapy; Saline Solution

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 8, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04