Not yet recruiting NCT06917599
Low-Level Laser Therapy vs. Saline for Wound Healing After Primary Molar Extraction.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-level laser, Saline Solution (NaCl 0,9%).
- Who it may be relevant to
- Registry conditions: Wound-healing. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect Of Low-Level Laser Therapy Versus Saline On Wound Healing Of Primary Molars Extraction: A Randomized Clinical Trial
Overview
To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars
Interventions
- Device Low-level laser
Effect of Low-level laser therapy 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
Primary outcome measures
- Presence of granulation tissue [Time frame: Follow-up day of, 3 days and 7 days after extraction]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06917599 · LLLT25