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
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
- 是
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
This arm will be given scaling and root planing (SRP) only
干预措施: Scaling and root planing (SRP) (Procedure)
Adjunctive photodynamic therapy
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
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
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
Zohaib Akram
Director, Clinical Research
King Saud University
