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NCT Number: NCT06917599

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

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

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Key information

Conditions

Wound-healing

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-level laser

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Rate of bleeding on palpation

    Time frame: Follow-up day of, 3 days, and 7 days after extraction

  3. 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)

  4. Assessment of gingival margin status

    Time frame: Follow-up day of, 3 days, and 7 days after extraction

  5. Size of wound

    Time frame: Follow-up day of, 3 days, and 7 days after extraction

  6. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect Of Low-Level Laser Therapy Versus Saline On Wound Healing Of Primary Molars Extraction: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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