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临床试验/NCT03308019
NCT03308019已完成不适用

Effectiveness of Scaling and Root Planing With and Without Adjunct Antimicrobial Photodynamic Therapy in the Treatment of Chronic Periodontitis Among Cigarette-smokers and Never-smokers: A Randomized Controlled Clinical Trial

King Saud University0 个研究点目标入组 83 人开始时间: 2016年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
主要终点
Clinical attachment level gain

研究概览

简要总结

This study evaluates the efficacy of scaling and root planing with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP) among cigarette-smokers and never-smokers.

详细描述

The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers; (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b) habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth; and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1 month and 3 months' follow-up.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
42 Years 至 52 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Self-reported habitual cigarette-smokers.
  • Self-reported never-smokers.
  • Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm.

排除标准

  • Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus.
  • Habitual smokeless tobacco product and alcohol users.
  • Third molars and fractured teeth with embedded root remnants and edentulous individuals.
  • Patients with misaligned teeth.
  • Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

研究组 & 干预措施

Dental scaling

Active Comparator

This arm will be given scaling and root planing (SRP) only

干预措施: Scaling and root planing (SRP) (Procedure)

Adjunctive photodynamic therapy

Experimental

This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)

干预措施: Photodynamic therapy (Device)

Adjunctive photodynamic therapy

Experimental

This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)

干预措施: Scaling and root planing (SRP) (Procedure)

Dental scaling

Active Comparator

This arm will be given scaling and root planing (SRP) only

干预措施: Photodynamic therapy (Device)

结局指标

主要结局

Clinical attachment level gain

时间窗: 3 months

Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.

Probing depth

时间窗: 3 months

Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)

次要结局

  • Plaque index(3 months)
  • Bleeding on probing(3 months)

研究者

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

Zohaib Akram

Director, Clinical Research

King Saud University

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