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临床试验/NCT03387371
NCT03387371Unknown不适用

Clinical and Microbiologic Effects of Nonsurgical Periodontal Treatment Combined With an Erbium: Yttrium Aluminium Garnet Laser

Bezmialem Vakif University0 个研究点目标入组 38 人开始时间: 2016年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
38
主要终点
Subgingival Plak Sample 1

研究概览

简要总结

Periodontitis is a chronic inflammatory disease caused by mixed infections with the subgingival microbiota being organized as a biofilm that, if untreated, may result in breakdown of the periodontal tissues in susceptible individuals. Evidence from intervention studies shows that mechanical root debridement significantly improves periodontal health by halting the progression of periodontal tissue breakdown. In order to improve effectiveness and efficacy of the removal of the subgingival biofilm, Er:YAG laser therapy has recently been recommended as an alternative to conventional scaling procedures.

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 (Participant, Investigator)

入排标准

年龄范围
28 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Greater than 25 years, Clinical diagnosis of moderate to advanced chronic periodontitis, Pocket depth ≥ 5 mm or clinic attachment level ≥ 4 mm at least in two interproximal areas (not on the same tooth), Along with very good oral hygiene scores (GI≤1and PI≤1), At least 4 teeth in each quadrant, Teeth with subgingival plaque sample is collected has no restoration or prothesis

排除标准

  • Periodontal treatment ( root planning or surgical periodontal treatment) had done before, Systemic disease that could influence the outcome of periodontal therapy, Prophylaxis regime mandatory during periodontal treatment, Use of any drug that could influence the outcome of periodontal therapy, Use of antibiotics within the last 3 months, Use of anti-inflammatory drugs within the last 3 months, Use of removable prothesis Pregnancy, lactation or use of hormone contraceptives, Smoking

研究组 & 干预措施

Ultrasonics & Gracey Curettes & Laser

Experimental

Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits.

干预措施: Er:YAG Laser (Device)

Ultrasonics & Gracey Curettes

Active Comparator

Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits.

干预措施: Ultrasonics (Device)

Ultrasonics & Gracey Curettes

Active Comparator

Scaling and root planning is done with ultrasonics and gracey curettes in 24 hours with two visits.

干预措施: Gracey Curettes (Device)

Ultrasonics & Gracey Curettes & Laser

Experimental

Scaling and root planning is done with ultrasonics, gracey curettes and Er:YAG laser in 24 hours with two visits.

干预措施: Gracey Curettes (Device)

结局指标

主要结局

Subgingival Plak Sample 1

时间窗: 1. month

quantitative changes on red complex bacterias

Clinic Attachment Level 6

时间窗: 6. month

to measure the Clinic Attachment Level of all teeth

Subgingival Plak Sample 3

时间窗: 3. month

quantitative changes on red complex bacterias

Probing Pocket Depth 3

时间窗: 3. month

to measure the probing pocket depth of all teeth

Clinic Attachment Level 3

时间窗: 3. month

to measure the Clinic Attachment Level of all teeth

Subgingival Plak Sample 6

时间窗: 6. month

quantitative changes on red complex bacterias

Probing Pocket Depth 6

时间窗: 6. month

to measure theProbing Pocket Depth of all teeth

次要结局

  • Bleeding On Probing 3(3. month)
  • Plak Index 3(3. month)
  • Plak Index 6(6. month)
  • Bleeding On Probing 6(6. month)

研究者

申办方类型
Other
责任方
Sponsor

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