Differences in Soft Tissue Healing and Vascularization Between Articaine and Lidocaine: A Randomized Clinical and Ultrasonographic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- early wound healing score (EHS)
研究概览
简要总结
The aim of this study is to compare and evaluate the effects of using lidocaine 2% (with adrenaline) and articaine 4% (with adrenaline) in free gingival graft (FGG) surgery on postoperative wound healing, changes in blood flow in the surgical area during the healing process, patients' postoperative pain levels, and anxiety levels before and after surgery.
详细描述
In a prospective randomised controlled trial conducted to investigate the effect of lidocaine and articaine on postoperative free gingival graft healing, wound healing was assessed using EHS, anxiety was assessed using VAS, STAI, and MDAS questionnaires, and ultrasonographic evaluations and PI measurements were used to determine whether there was a difference in wound healing between the two anaesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients> 18 years requiring FGG surgery with ≤ 1 mm width of attached gingiva
- •No systemic diseases or pregnancy.
- •Smoking ≤10 cigarettes/day
- •Full-mouth plaque score and full-mouth bleeding score ≤10% (four sites per tooth).
- •Need for FGG due to insufficient attached gingiva
- •No history of mucogingival or periodontal surgery at experimental sites
排除标准
- •Use of oral contraceptives, psychotropic drugs, sedatives, or NSAIDs
- •Allergy or hypersensitivity to local anesthetics,
- •Orofacial neurological symptoms,
- •Active infection in the surgical area,
- •Pathological mental conditions such as dementia or psychosis, or lack of cooperation,
研究组 & 干预措施
lidocaine HCL
Participants will receive lidocaine HCL 2% with adrenaline for local anesthesia before free gingival surgery once only
干预措施: Free gingival graft (FGG) (Procedure)
articaine HCL
Participants will receive articaine HCL 4% with adrenaline for local anestesia before free gingival surgery once only
干预措施: Free gingival graft (FGG) (Procedure)
结局指标
主要结局
early wound healing score (EHS)
时间窗: 3rd day, 7th day, 14th day
The healing of the recipient site was evaluated using the EHS index during clinical exams on postoperative days 3, 7, and 14. The EHS index includes parameters of hemostasis (CSH), inflammation (CSI), and re-epithelialization (CSR). The total score ranges from 0 (worst healing) to 10 (best healing)
次要结局
- Ultrasonographic Evaluations(3rd, 7th, and 14th days)
- Modified Dental Anxiety Scale (MDAS)(baseline and 14 days after the procedure,)
- State-Trait Anxiety Inventory (STAI-S and STAI-T)(baseline and 14 days after the procedure,)
研究者
AYSAN LEKTEMUR ALPAN
Head of Periodontology Department
Pamukkale University