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临床试验/NCT05449964
NCT05449964Unknown不适用

Comparative Evaluation of Outcomes of Single Sitting Scaling and Root Planing (SRP) vs Supra-gingival Scaling Followed by Sub-gingival Scaling and Root Planing After One Week: a Split-mouth Randomised Controlled Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
27
试验地点
2
主要终点
Change in bleeding on pocket probing (BOPP)

研究概览

简要总结

The primary course of periodontal treatment is non-surgical periodontal therapy followed by surgical therapy, if required, with an aim to arrest ongoing inflammatory periodontal destruction along with reconstruction of lost apparatus if possible. There is no protocol established for completing scaling and root planing (SRP) in patients with generalized advanced periodontitis. In some cases SRP is completed in single sitting whereas in other cases supragingival scaling is followed by subgingival SRP in the next appointment. It is hypothesized that presence of reparative components near the base of the pocket could result in better treatment outcomes after scaling and root planning done in single sitting when compared to supragingival scaling followed by sub-gingival scaling and root planning after one week.

详细描述

The aim of this randomized controlled clinical trial is to clinically compare the outcomes of scaling and root planing (SRP) completed in single sitting vs supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.

OBJECTIVES:

  1. To assess the improvement in clinical parameters viz. bleeding on pocket probing (BOPP), pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on marginal probing (BOMP), gingival marginal position (GMP) and gingival recession (GR) by single sitting scaling and root planning versus supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.
  2. To assess the correlation between availability of Vascular Endothelial Growth Factor (VEGF) at the base of the pocket and treatment outcomes.

SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.

STUDY DESIGN: Split-mouth Randomized controlled clinical trial.

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)

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.

排除标准

  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Mobile teeth (Mobility no. 2 and 3 as per Miller Index)
  • Patient taking medications such as NSAIDS, corticosteroids, statins or calcium channel blockers, which are known to interfere with periodontal wound healing.
  • Pregnant or lactating women.
  • History of use of tobacco.
  • History of periodontal treatment in last 2 years.

结局指标

主要结局

Change in bleeding on pocket probing (BOPP)

时间窗: 6 MONTHS

CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS

Chane in pocket probing depth (PPD)

时间窗: 6 MONTHS

CHANGE IN POCKET PROBING DEPTH FROM BASELINE TO 6 MONTHS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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