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临床试验/NCT06086821
NCT06086821已完成不适用

Clinical Relevance of Different Time of Periodontal Re-evaluation

University of Florence2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Number of Teeth not reaching EoT (Endpoint of treatment)

研究概览

简要总结

Treatment of periodontitis follows an incremental step approach. The results after step 1 (Oral Hygiene Instruction and Professional Mechanical Plaque Removal) and 2 (subgingival instrumentation) are re-evaluated in order to understand whether the endpoints of therapy have been achieved.

The case reevaluation may be performed at different time intervals, ranging from 2 weeks to 6 months. The aim of this study is to compare two different timing of re-evaluation, in terms of clinical indexes (PPD reduction; Pocket closure) and patients' morbidity (number of further therapies needed).

详细描述

Treatment of periodontitis follows an incremental step approach in which the first step is aimed at modifying patient behavior with the goal of supragingival plaque reduction.

The second step is subgingival instrumentation, performed with different instruments and treatment timing and with or without additional therapies. However, in periodontitis patients, the complete removal of subgingival biofilm and calculus at teeth with deep probing depths (≥6 mm) or complex anatomical surfaces (root concavities, furcations, infra bony pockets) may be difficult, and hence, the endpoints of therapy may not be achieved, and further treatment should be implemented.

The third step of therapy is aimed at treating those areas of the dentition non-responding adequately to the second step of therapy (presence of pockets ≥4 mm with bleeding on probing or presence of deep periodontal pockets [≥5 mm]), with the purpose of gaining further access to subgingival instrumentation, or aiming at regenerating or resecting those lesions that add complexity in the management of periodontitis (intra-bony and furcation lesions).

Periodontal reevaluation is performed after step 2. The case reevaluation, executed after the completion of the first step of periodontal therapy, allows to assess the response to therapy, to specify the prognosis of the case and the possible need for further treatment and, consequently, to finalize and correct the case's periodontal treatment plan.

Many different time intervals, ranging from 2 weeks to 6 months, have been documented in periodontal literature to be the best time to perform reevaluation.

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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor does not know when Step 1 and 2 of periodontal treatment have been performed.

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

  • Adults with a diagnosis of Generalized, stage III or stage IV periodontitis;
  • At least 20 teeth present
  • At least eight teeth must show probing pocket depths (PPD) of ≥5mm and bleeding on probing (BOP). At least two of these teeth must have a PPD of ≥7 mm and at additional two teeth, the pockets must measure ≥6 mm;

排除标准

  • Patients receiving periodontal treatment in the past 12 months;
  • Patients receiving antibiotics in the past 3 months;
  • Known medical conditions that affects the progression of periodontitis or that affect the outcomes of periodontal therapy;
  • Compromised medical conditions requiring prophylactic antibiotic coverage; and ongoing drug therapy that might affect the clinical signs and symptoms of periodontitis.

结局指标

主要结局

Number of Teeth not reaching EoT (Endpoint of treatment)

时间窗: 6 months after step 2 of periodontal treatment is completed

Number of Teeth Needing further treatments

次要结局

未报告次要终点

研究者

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

Luigi Barbato

Principal Investigator

University of Florence

研究点 (2)

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