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临床试验/NCT05798871
NCT05798871进行中(未招募)不适用

Impact of Erythritol Air-polishing as a Sole Treatment in the Initial Healing of Shallow Periodontal Pockets

University of Baghdad2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
2
主要终点
Pocket depth

研究概览

简要总结

Periodontitis is an inflammation associated with destruction of the periodontium that ultimately, if not treated, leads to tooth loss. Clinically, it is characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession. The standard periodontitis treatment aims to restore the homeostasis of the immune system by mechanically reducing the microbial load to levels that are compatible with stability and health. This is achieved by professional mechanical biofilm control and motivation of the patient for oral hygiene measures in order to control the biofilm and avoid disease recurrence. Conventional scaling and root planing (SRP), and air polishing therapy are tools used for professional biofilm control. More recently, air-polishing devices have become a promising alternative to conventional SRP in reducing the clinical time and causing less discomfort and pain for the patients. The objective of this study is to evaluate the efficacy of subgingival erythritol air polishing for initial periodontal pocket healing.

详细描述

Periodontitis results from a polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. Thus, the inability of the host immune system to eliminate the biofilm insult leads to a complex chronic response with the destruction of bone and periodontal ligament attachment. The main goal of periodontal therapy is to arrest further attachment loss and, consequently, prevent further disease progression and subsequent tooth loss. In most cases, this goal can be predictably achieved by means of non-surgical periodontal therapy using hand, ultrasonic instruments and air polishing devices. Treatment with scaling and root planing often results in an additional increase of root hypersensitivity, thus impairing the patient's quality of life. Minimally invasive periodontal therapy primarily focus on calculus removal and effective removal of the biofilm rather than on excessive and intentional removal of root cementum.

Air polishing with erythritol powder seems more effective than manual instrumentation at disrupting biofilm in both shallow and deep pockets, whilst it is more gentle on the root surface and soft tissues, and allowing proper attachment of periodontal ligament fibroblasts.

Erythritol powder air-polishing with ultrasonic debridement has reported to need less time than ultrasonic debridement with polishing during periodontal therapy.Therefore, this study will evaluate the impact of erythritol air polishing in resolving periodontal pockets.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants should be medically healthy with periodontitis.
  • Participants should have generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C.
  • Only teeth with single root will be included.

排除标准

  • Participants who have active cavity caries, endodontic treatment.
  • Participants who have ongoing orthodontic treatment.
  • Participants who have been on antibiotics within the past 4 months.
  • Participants who require prophylactic antibiotic coverage.
  • Participants who have been on systemic or topical non-steroidal anti- inflammatory drugs for the past 4 months.
  • Participants who are pregnant or intended to and lactating mother.
  • Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses.
  • Participants who have any systemic disease and smokers.

结局指标

主要结局

Pocket depth

时间窗: 1 month

Change of pocket depth (in mm) one month after treatment

次要结局

  • Bleeding on probing(1 month)
  • Mean relative changes in beta catenin levels in gingival crevicular fluid.(1 month)
  • Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid(1 month)
  • Clinical attachment loss(1 month)
  • Plaque index(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hayder Raad Abdulbaqi

principal investigator

University of Baghdad

研究点 (2)

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