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临床试验/NCT01098448
NCT01098448已完成3 期

Control of Periodontal Infections

The Forsyth Institute1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 1999年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

scaling and root planing as a solo therapy

干预措施: scaling and root planing (Other)

Periodontal surgery

Experimental

干预措施: surgery (Other)

systemic antibiotics

Experimental

干预措施: systemic metronidazole and amoxicillin (Drug)

Local delivery of tetracycline

Experimental

干预措施: local tetracycline (Drug)

local antibiotic and systemic antibiotics

Experimental

干预措施: local antibiotics and systemic metronidazole and amoxicillin (Drug)

local antibiotics and surgery

Experimental

干预措施: local tetracycline and periodontal surgery (Other)

systemic antibiotics and surgery

Experimental

干预措施: periodontal surgery and systemic metronidazole and amoxicillin (Other)

local and systemic antibiotics and surgery

Experimental

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)

研究者

申办方类型
Other

研究点 (1)

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