A Randomized Single-Blind Clinical Trial Comparing the Clinical and Radiographic Outcomes of the Vector® Ultrasonic System and Minimally Invasive Hand Instrumentation (Mini-Five Curettes) in Non-Surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Probing Depth(PD)
研究概览
简要总结
This randomized clinical trial aims to compare the clinical and radiographic outcomes of the Vector®️ ultrasonic system and mini-five curettes in non-surgical periodontal therapy. Patients diagnosed with periodontitis will be randomly assigned to either ultrasonic instrumentation or manual instrumentation. Clinical periodontal parameters and radiographic bone level changes will be evaluated at baseline, 1, 3, 6, and 12 months. The primary objective is to assess differences in clinical attachment level and probing depth reduction between the two treatment modalities.
详细描述
Periodontitis is a chronic inflammatory disease leading to the destruction of supporting periodontal tissues. Non-surgical periodontal therapy is the first-line treatment and includes mechanical debridement using manual or ultrasonic instruments. The Vector®️ ultrasonic system is designed to provide minimally invasive debridement with reduced trauma to root surfaces and surrounding tissues.
This randomized, controlled, single-blind clinical trial will compare the effectiveness of the Vector®️ system and mini-five curettes in patients diagnosed with periodontitis. Participants will be randomly allocated into two groups: the ultrasonic instrumentation group (Vector®️ system) and the manual instrumentation group (mini-five curettes).
Clinical parameters including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be recorded at baseline and at 1, 3, 6, and 12 months. Standardized radiographic examinations will be performed at baseline, 6 months, and 12 months to evaluate radiographic bone level changes.
The primary outcome measure is the change in clinical attachment level at 12 months. Secondary outcomes include probing depth reduction, bleeding on probing, and radiographic bone level changes.
The study is conducted at Hacettepe University Faculty of Dentistry, Department of Periodontology. Ethical approval has been obtained from the Hacettepe University Clinical Research Ethics Committee.
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)
盲法说明
The examiner responsible for clinical measurements is blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years Willing to participate and provided written informed consent Presence of single-rooted teeth in both maxilla and mandible with vertical bone defects (radiographic intrabony defect ≥2 mm and probing depth ≥5 mm) Diagnosis of Stage III or Stage IV periodontitis Systemically healthy or Systemically healthy patients or American Society of Anesthesiologists (ASA) physical status I-II.
排除标准
- •Periodontal treatment within the last 6 months Teeth with furcation involvement Smoking more than 10 cigarettes per day Pregnancy Age under 18 years Patients unwilling to attend regular follow-up visits Previously endodontically treated tooth at the treatment site Poor compliance with oral hygiene instructions Single-rooted teeth with horizontal bone loss extending close to the apical third Teeth with mobility grade II or III Previous flap surgery or regenerative periodontal treatment at the study site
研究组 & 干预措施
Vector System Group
Participants receive non-surgical periodontal therapy using the Vector®️ ultrasonic system.
干预措施: Vector® Ultrasonic System (Device)
Mini-Five Curettes Group
Participants receive non-surgical periodontal therapy using mini-five curettes.
干预措施: Mini-Five Curettes (Device)
结局指标
主要结局
Change in Probing Depth(PD)
时间窗: Baseline,1 month, 3 months, 6 months, and 12 months
Change in periodontal probing depth (in millimeters) from baseline to follow-up after non-surgical periodontal therapy using Vector®️ ultrasonic system compared with mini-five curettes.
Change in Radiographic Vertical Bone Defect Depth
时间窗: Baseline, 6 months, and 12 months
Change in radiographic vertical bone defect depth (mm) assessed on standardized radiographs at baseline, 6 months, and 12 months after treatment.
次要结局
- Pain Sensitivity(VAS Score)(During treatment and immediately after treatment)
研究者
Serife Kosar
Research Assistant Dentist
Hacettepe University