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临床试验/NCT04964167
NCT04964167已完成4 期

Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis

Riyadh Elm University2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2021年9月7日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis

研究概览

简要总结

For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to scaling and root planning (SRP) for treatment of chronic periodontitis.

One hundred and fifty patients included in this study were randomly distributed in three treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent assay (ELISA) technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age of ≥ 30 years;
  • ≥ 20 natural teeth; and
  • chronic-periodontitis (≥ 3 mm of CAL and PD pocket depth respectively on at least 30% of dental sites).

排除标准

  • chronic systemic diseases;
  • PD therapy during last 6 months;
  • habitual use of chewable and non-chewable tobacco (smoking);
  • alcohol consumers; or
  • use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)

结局指标

主要结局

Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis

时间窗: 9 months

Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue

IL-6 concentration in pg/ml

时间窗: 6 months

Identify the concentration of IL-6 in the gingival crevicular fluid

Clinical attachment loss in mm

时间窗: 6 months

Periodontal attachment loss

TNF-α levels in pg/ml

时间窗: 6 months

Identify the concentration of TNF-α in the gingival crevicular fluid

IL-8 concentration in pg/ml

时间窗: 6 months

Identify the concentration of IL-8 in the gingival crevicular fluid

Periodontal pocket depth in mm

时间窗: 6 months

Periodontal pocket depth

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

Zeeshan Qamar

Assistant Professor

Riyadh Elm University

研究点 (2)

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