Control of Periodontal Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level Gain
研究概览
简要总结
The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis.
详细描述
In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •greater than 20 years of age
- •had a least 15 natural teeth
- •in good general health
- •at least 4 teeth with pockets > 6 mm
- •at least 8 teeth with AL > 3 mm at baseline
排除标准
- •pregnant or nursing (if female)
- •having antibiotic or periodontal therapy in the previous three months
- •systemic conditions that would affect the course of periodontal disease
- •systemic conditions that required antibiotic coverage
- •allergic to drugs used in the study
研究组 & 干预措施
Scaling and root planing
scaling and root planing as a solo therapy
干预措施: scaling and root planing (Other)
Periodontal surgery
干预措施: surgery (Other)
systemic antibiotics
干预措施: systemic metronidazole and amoxicillin (Drug)
Local delivery of tetracycline
干预措施: local tetracycline (Drug)
local antibiotic and systemic antibiotics
干预措施: local antibiotics and systemic metronidazole and amoxicillin (Drug)
local antibiotics and surgery
干预措施: local tetracycline and periodontal surgery (Other)
systemic antibiotics and surgery
干预措施: periodontal surgery and systemic metronidazole and amoxicillin (Other)
local and systemic antibiotics and surgery
干预措施: surgery, local tetracycline, systemic metronidazole and amoxicillin (Other)
结局指标
主要结局
Clinical Attachment Level Gain
时间窗: 24 months
次要结局
- Probing pocket depth reduction(24 months)
