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临床试验/NCT02215460
NCT02215460已完成4 期

Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial

University of Taubate1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
Improvements in pocket depth and clinical attachment level measurements

研究概览

简要总结

Periodontitis is a form of gum disease that affects many people in the world. Its traditional protocol of treatment includes oral hygiene instruction and dental scaling to remove debris, dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option also usually cheaper. In this last one, all above described procedures are performed within 24 hours. However, up to now comparative effectiveness between these both types of treatment is not well understood. For, example it is not clear if patients treated in the shorter-time experienced more pain. Therefore, the present study used several parameters to clarify whether beneficial differences between these therapeutic protocols exist or not. In addition, aspects that could help clinicians' and patient's decisions such as experience of pain and anxiety related to dental treatment were also investigated. After receiving verbal and written explanations and signed the informed consent form 150 individuals (n=15/group) having the most common type of periodontitis in adults were randomly allocated to be treated in 4 weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were performed alone or in conjunction with antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral debris and malodor; quantification of bacteria in plaque samples collected with paper points from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect information about oral condition, daily activities, pain and anxiety related to dental 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • mild to moderate chronic periodontitis;
  • at least 20 natural teeth;
  • good general health

排除标准

  • systemic diseases or other conditions that could influence the periodontal status;
  • events of high blood pressure or diagnosed hypertension;
  • alcohol abuse;
  • orthodontic devices;
  • extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
  • pregnancy or breast-feeding;
  • history of sensitivity or suspected allergies following the use of oral hygiene products and/or the test antibiotic;
  • the need for antibiotic prophylaxis;
  • antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
  • regular use of chemotherapeutic antiplaque/antigingivitis products;
  • any furcation lesions;
  • periodontal treatment performed within six months prior to study initiation;
  • unwillingness to return for follow-up.

研究组 & 干预措施

Full-mouth scaling (FMS)

Experimental

干预措施: FMS full-mouth scaling (Procedure)

FMS chlorhexidine rinse

Experimental

干预措施: FMS full-mouth scaling (Procedure)

FMS chlorhexidine rinse

Experimental

干预措施: FMS chlorhexidine rinse (Drug)

FMS azithromycin tablets

Experimental

干预措施: FMS full-mouth scaling (Procedure)

FMS azithromycin tablets

Experimental

干预措施: FMS azithromycin tablets (Drug)

FMS placebo rinse

Placebo Comparator

干预措施: FMS full-mouth scaling (Procedure)

FMS placebo rinse

Placebo Comparator

干预措施: FMS placebo rinse (Drug)

Quadrant scaling (QS)

Experimental

干预措施: QS quadrant scaling (Procedure)

QS chlorhexidine rinse

Experimental

干预措施: QS quadrant scaling (Procedure)

QS chlorhexidine rinse

Experimental

干预措施: QS chlorhexidine rinse (Drug)

QS azithromycin tablets

Experimental

干预措施: QS quadrant scaling (Procedure)

QS azithromycin tablets

Experimental

干预措施: QS azithromycin tablets (Drug)

QS placebo tablets

Placebo Comparator

干预措施: QS quadrant scaling (Procedure)

QS placebo tablets

Placebo Comparator

干预措施: QS placebo tablets (Drug)

FMS placebo tablets

Placebo Comparator

干预措施: FMS full-mouth scaling (Procedure)

FMS placebo tablets

Placebo Comparator

干预措施: FMS placebo tablets (Drug)

QS placebo rinse

Placebo Comparator

干预措施: QS quadrant scaling (Procedure)

QS placebo rinse

Placebo Comparator

干预措施: QS placebo rinse (Drug)

结局指标

主要结局

Improvements in pocket depth and clinical attachment level measurements

时间窗: Changes in pocket depth and clinical attachment level measurements from baseline to 6 months

Primary outcomes of effectiveness were improvements of the following clinical parameters: periodontal pocket depth (mm) and clinical attachment level (mm) from baseline to 6 months.

次要结局

  • Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines(3 months)
  • Changes in total bacterial load and levels of selected pathogens(3 months)
  • Improvements in plaque index and gingival index(Changes from baseline to 3 months)
  • Maintenance of pocket depth and clinical attachment level measurements(Changes in pocket depth and clinical attachment level from 6 months to 9 months)

研究者

发起方
University of Taubate
申办方类型
Other
责任方
Sponsor

研究点 (1)

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