Evaluation of Patients' Perceptions and Soft Tissue Changes After Conventional and Diode Laser Frenectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Postoperative tissue healing
研究概览
简要总结
The goal of this clinical trial is to determine if diode laser treatment can improve post-operative outcomes compared to conventional scalpel technique in systemically healthy, non-smoking adults aged 18-45 years with aberrant papillary frenum attachment. The main questions it aims to answer are:
Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique? Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique? Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing.
Participants will:
Undergo a frenectomy procedure using either a diode laser or a conventional scalpel.
Receive oral hygiene instructions and post-operative care recommendations. Have their periodontal parameters measured at baseline, 6 weeks, and 6 months post-operation.
Record their pain levels using a visual analogue scale on specified post-operative days.
详细描述
The trial will be performed as a prospective, randomized and controlled, single-blind investigation to study clinical parameters and patients' experiences when performing a frenectomy, comparing diode laser treatment with the conventional scalpel technique.
Participants:
This study will include 43 participants who will be identified with aberrant papillary frenum attachment according to Mirko et al., and will be referred to the periodontology department. The inclusion criteria for the participants will be:
All participants will sign a written informed consent form before participating in the study.
Study Groups and Randomization:
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
- None
盲法说明
Patients in the C group underwent primary wound healing with sutures, whereas patients in the L group did not get any sutures. Therefore, neither the clinicians (Z.T.E and K.Y) nor the patients were kept unaware of the study's details over the entire duration
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy
- •Nonsmoker
- •No periodontal treatment received in the last 3 months
- •Having at least 20 teeth
- •Presence of at least central incisors, lateral incisors, and canines in the maxilla
- •Not pregnant or breastfeeding
- •No psychiatric, mental, or physical impairments
- •Diagnosed with gingival health based on the "World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
- •Consent to participate in the study.
排除标准
- •Any systemic disease that could interfere with the wound healing process (e.g., diabetes mellitus and HIV infection)
- •Use of antibiotics, anti-inflammatory drugs, or any other medication in the last 6 months that could affect the study's outcome
- •Any hypersensitivity reactions to paracetamol
- •Any physical limitations or restrictions that could impede normal oral hygiene procedures.
结局指标
主要结局
Postoperative tissue healing
时间窗: postoperative days 7 and 30 after surgery,
Tissue healing will be assessed by Z.T.E using the following scoring system: * Score 1: Complete epithelialization * Score 2: Incomplete epithelialization * Score 3: Presence of ulcer * Score 4: Tissue defect or necrosis
Postoperative pain
时间窗: postoperative days 1, 3, 7, 14, 21, and 28.
Pain will be evaluated using the visual analogue scale (VAS).The scale will be comprised of a horizontal line with values ranging from '0' to '10', where '0' indicates the absence of pain and '10' indicates the presence of severe discomfort.
次要结局
未报告次要终点
研究者
Zeynep Tastan Eroglu
Assistant professor
Necmettin Erbakan University