Effect of the Diode Laser on Bacteremia Associated With Periodontal Flap Surgery: A Clinico-Microbiological Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of bacteremia using PCR
研究概览
简要总结
The objective of the present study is
- To study the incidence and magnitude of bacteremia after periodontal flap surgery .
- To compare and evaluate the effect of diode laser on frequency of bacteremia associated with periodontal flap surgery .
- To study the incidence of bacteremia after laser therapy
详细描述
SOURCE OF DATA Patient visiting the Outpatient Section of the Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital will be screened and randomly recruited for the study as per inclusion and exclusion criteria. The eligible subjects will be informed of the nature and benefits of the participation of the study and a written signed consent will be obtained. The study population will consist of twenty (n=20) subjects who will be age (30 to 40 years) and sex matched.
Sample Size The study was performed according to split- mouth design, and all teeth in the mouth were treated randomly using either the left or the right side of the maxilla and mandible for control , and the opposite side for the therapy. Each patient was entered into a clinical protocol consisting of two different treatment modalities.
Group I (n=10) - Test group ( diode laser + flap surgery) Group II (n=10) - control group (flap surgery)
SURGICAL PROCEDURE GROUP I (TEST GROUP) Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W.
Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (investigator and outcome Assessor)
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient with age 30 -40 years .
- •Systemically healthy patients.
- •Patients having probing depth of ≥ 5mm and ≤ 8 mm at minimum of two sites and good level of oral hygiene after initial therapy.
- •No signs of gingival inflammation
排除标准
- •Patient with history of smoking, antibiotic therapy within the previous three months.
- •Patient with subgingival restorations and use of antiseptic mouthwash.
- •Congenital or acquired cardiac defects, cardiac prosthesis.
- •Hematological disorder.
- •Immunocompromised patients
结局指标
主要结局
Assessment of bacteremia using PCR
时间窗: After 24 hours of collection
Bacteremia in venous blood before starting the procedure, after 5 minutes and within 30 minutes of the start of the procedure
次要结局
未报告次要终点
研究者
Dr Prabhuji MLV
proffesor/ Head of the department Periodontology
Krishnadevaraya College of Dental Sciences & Hospital