Clinical and Microbiological Evaluation of Techniques for Scaling and Root Planing Per Quadrant and One Stage Full Mouth Disinfection Associated With Azithromycin or Chlorhexidine: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in clinical attachment
研究概览
简要总结
Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin.
详细描述
Seventy -seven systemically healthy subjects with chronic periodontitis were randomly included in 6 different predefined groups. The following periodontal parameters were evaluated: probing depth , clinical attachment level , plaque index, gingival index and percentage of areas affected by periodontal disease. Microbiologically were evaluated the bacterial load and specific load of five bacterias: The quantification of the bacteria was performed by real-time Polymerase Chain Reaction . The clinical and microbial baseline evaluations were performed ( periodontal pre- therapy) , 90 and 180 days after treatment.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of slight-moderate chronic periodontitis
排除标准
- •Those who were making regular use of antibiotics or anti-inflammatory drugs or had done up to three months before the beginning of the study;
- •those who were making regular use (twice a day) of oral rinses with chlorhexidine or essential oils or have made regular use within three months prior to study entry;
- •individuals with a history of sensitivity to chlorhexidine or azithromycin;
- •subjects undergoing periodontal therapy include dental scaling procedures in the 12 months preceding the start of the study;
- •subjects with impaired bifurcation or trifurcation class III;
- •who required antibiotic prophylaxis for conducting clinical periodontal examination
- •subjects with removable partial dentures and removable or fixed orthodontic appliance.
研究组 & 干预措施
Full mouth disinfection - FMD
n = 10: Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
干预措施: Full mouth disinfection (Procedure)
FMD + chlorhexidine (FMD-CX)
n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase.
干预措施: Full mouth disinfection (Procedure)
SRP + azithromycin (SRP-AZ)
n = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the last scaling hemi-arch;
干预措施: Scaling and root planing (Procedure)
FMD + chlorhexidine (FMD-CX)
n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase.
干预措施: Chlorhexidine gel and gluconate (Drug)
FMD + chlorhexidine (FMD-CX)
n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase.
干预措施: Chlorhexidine gluconate solution (Drug)
FMD + azithromycin (FMD-AZ)
n = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the scaling.
干预措施: Full mouth disinfection (Procedure)
FMD + azithromycin (FMD-AZ)
n = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the scaling.
干预措施: Azithromycin (Drug)
Scaling and root planing (SRP)
(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
干预措施: Scaling and root planing (Procedure)
SRP + azithromycin (SRP-AZ)
n = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the last scaling hemi-arch;
干预措施: Azithromycin (Drug)
SRP + chlorhexidine (SRP-CX)
n = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling
干预措施: Scaling and root planing (Procedure)
SRP + chlorhexidine (SRP-CX)
n = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling
干预措施: Chlorhexidine gluconate solution (Drug)
结局指标
主要结局
Change in clinical attachment
时间窗: Baseline and 180 days after treatment
In this parameter we will evaluate the distance from the cement-enamel junction to the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters
次要结局
- Change in probing depth(Baseline and 180 days after treatment)
研究者
Douglas Campideli Fonseca
Master of Science
Centro Universitario de Lavras