NCT06917599尚未招募不适用
Effect Of Low-Level Laser Therapy Versus Saline On Wound Healing Of Primary Molars Extraction: A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Presence of granulation tissue
研究概览
简要总结
To evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary Molars
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● 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.
排除标准
- •● 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.
研究组 & 干预措施
Low-level laser therapy
Experimental
Effect of Low-level laser therapy in wound healing after primary molar extraction
干预措施: Low-level laser (Device)
Saline
Active Comparator
Normal saline in wound healing after primary molar extraction
干预措施: Saline Solution (NaCl 0,9%) (Other)
结局指标
主要结局
Presence of granulation tissue
时间窗: 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
次要结局
- Rate of bleeding on palpation(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)
- Assessment of tissue color(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)
- Size of wound(Follow-up day of, 3 days, and 7 days after extraction)
- Rate of post operative pain(Follow-up day of, 3 days, and 7 days after extraction)
研究者
Hadeer Mostafa Kamel Sallem
Principal Investigator
Cairo University
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