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临床试验/NCT04074915
NCT04074915已完成不适用

Effects of 1% Matricaria Chamomile Mouth Rinse for the Management of Chronic Periodontitis: a Double Blind Randomized, Placebo Controlled Clinical Trial

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Clinical attachment loss

研究概览

简要总结

This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month while clinical parameters [plaque index (PI), gingival index (GI), sulcus bleeding index (SBI), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (GR), stain index (SI)] were evaluated at base line, 1 month, and 3 months. CFU was also evaluating at above said time periods.

详细描述

This double blind, randomized, placebo controlled, parallel clinical trial involved seventy five patients, suffering with chronic periodontitis, which were randomly divided in three groups: negative control (SRP+placebo), positive control (SRP+0.12% CHX), and test group (SRP+1% MTC mouth rinse). Mouth rinsing (adjunctive therapy) was continued for 1 month.The primary outcome of this study was CAL, while PPD was the secondary outcome measure. A single clinician (AA) who was blinded to the groups assigned to the individuals, recorded all the parameters i.e. PI, GI, SBI, PPD, CAL, GR, SI at base line (prior to the treatment), 1 and 3 months after therapy. PPD, CAL and GR were recorded at the six sites per tooth in every tooth, except third molar, with a manual UNC-15 periodontal probe (Hu-Friedy, Leinmen, Germany) to the nearest millimeter. For recording of parameters at different time periods patients were instructed to refrain from any oral hygiene procedure for 8 hours prior to the evaluation. Staining of the six maxillary anterior teeth was assessed using the Lobene index. CFUs of P. ginigvalis, T. forsythia, and T. denticola were evaluated at baseline , 1 months, 3 months.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy individuals of > 30 years of age with previously untreated generalized chronic periodontitis (defined by Armitage in 1999),
  • having minimum 15 teeth,
  • minimum of six teeth with at least one interproximal site with PPD between 5-7mm,
  • CAL between 5-10 mm, at least 30% of the sites with PPD and CAL ≥ 5 mm
  • presence of bleeding on probing (BOP).

排除标准

  • was any systemic disease,
  • use of any medication in the previous 6 months,
  • subjects wearing partial removal prosthesis or orthodontic appliance,
  • allergy to ingredient used in the study, alcoholics, smokers or tobacoo users in any form, mentally retarded individual, pregnant or lactating females.

研究组 & 干预措施

Placebo rinse

Placebo Comparator

Normal saline

干预措施: Placebo mouth rinse (Other)

Chlorhexidine mouth rinse

Experimental

Chlorhexidine mouth rinse

干预措施: Chlorhexidine mouth rinse (Drug)

Test group

Experimental

Chamomile mouth rinse

干预措施: Test group (Drug)

结局指标

主要结局

Clinical attachment loss

时间窗: 3 Months

Distance from cemento enamel junction to base of the pocket

次要结局

  • Probing pocket depth(3 Months)
  • colony forming units(3 months)

研究者

发起方
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

ASHISH AGARWAL

Clinical professor, institute of dental sciences, bareilly

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

研究点 (1)

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