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临床试验/CTRI/2024/01/061413
CTRI/2024/01/061413尚未招募不适用

Evaluation of the safety and the efficacy of a novel polyherbal mouthwash containing Emblica officinalis,Cinnamomum cassia,Silicate of magnesia,Nigella sativa and Eucalyptus globulus oil in patients with gingivitis:A randomized controlled trial

DR ZADC AMU ALIGARH1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
1)DECREASE IN SALIVARY CRP LEVEL

研究概览

简要总结

Periodontal diseases have adestructive effect on the supporting tooth tissues. The mildest form of thesediseases is gingivitis which is characterized by bleeding, plaque

formation  andgum inflammation .Several lines of evidence haveshown that elimination of microbial dental plaque biofilm prevents gingivitis. In addition to mechanical oral

hygiene approaches, there is a need for additional measures to controlbacterial plaque formation by using antimicrobial dentifrices or anti-plaque

mouthwashes. Chlorhexidine,  a bisguanideis considered benchmark of antimicrobial rinses due to its high substantivityand wide range of activity. Chlorhexidine is  not a

‘Miraculous solution’ as it hasdefinite  after effects like taste alteration, mucosal irritation, dry mouth,tooth discoloration, cytotoxic effect.Based on the ill-effects of

chlorhexidine, World Health Organization admonishedresearchers to probe the potential of herbs and plant extracts. Hence, finding newer antiplaqueand

antimicrobial agents with a natural origin is important to increasetreatment compliance and reduce adverse effects upon long-term application. In dentistry,

Herbal concentrateswere used to lessen  inflammation, prevent dental caries, to heal gingivitis& periodontitis, and as antimicrobials & antioxidants. The

natural products used in thisstudy were Indian gooseberry (Emblica  Officinalis), cinnamon(Cinnamomum Cassia), HydratedMagnesium silicate(silicate of

magnesia), Black seed(Nigella Sativa),Eucalyptus oil(Eucalyptus Globulus) .Theefficacy of all the substances were proven individually. The combined effect of

the substances was not studied previously . Thus the aim of the study was toevaluate the clinical safety and efficacy of polyherbal mouthwash containing Indian

gooseberry, Cinnamon, Hydrated magnesium silicate, black seed And Eucalyptus oil against commerciallyavailable chlorhexidine mouthwash.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • APPARENTLY HEALTHY INDIVIDUALS WITH PRESENCE OF ATLEAST 20 NATURAL TEETH DIAGNOSIS OF GINGIVITIS-DENTAL BIOFILM INDUCED.

排除标准

  • PREGNANCY AND LACTATION 2)DECOMPENSATED SYSTEMIC DISEASE 3)DEGENERATIVE BONE DISEASE 4)SJOGREN SYNDROME 5)ADVANCED PERIODONTAL OR ORTHODONTIC DISEASE 6)HISTORY OF ORAL PROPHYLAXIS WITHIN 6 MONTHS 7)HISTORY OF TAKING ANTIBIOTICS,ANTICOAGULANT,IMMUNOSUPPRESSIVE,ANTI-INFLAMMATORY MEDICATION OR USING ANTI-BACTERIAL MOUTH RINSES FOR PAST 6 MONTHS.
  • SMOKING,DRUG AND ALCOHOL ABUSE.

结局指标

主要结局

1)DECREASE IN SALIVARY CRP LEVEL

时间窗: three months

2)DECREASE IN GINGIVAL INDEX,GINGIVAL BLEEDING INDEX,PLAQUE INDEX

时间窗: three months

次要结局

  • effectiveness of polyherbal mouth wash(three months)

研究者

发起方
DR ZADC AMU ALIGARH
申办方类型
Government medical college

研究点 (1)

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