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临床试验/CTRI/2022/09/045284
CTRI/2022/09/045284已完成不适用

Comparison of tooth staining effect of chlorhexidine mouthwashes with and without Anti-Discoloration System among Institutionalized geriatric population - A Randomized controlled trial

Dr Karunanidhi K2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
To assess and compare the presence of extrinsic staining of teeth after the use of chlorhexidine mouthwashes with and without discoloration system.

研究概览

简要总结

Dentists frequently recommend adjunctive oral hygiene aids such  as chlorhexidine (CHX) mouthwashes. CHX represents an effective option for the treatment of plaqueâ€induced gingival diseases, due to inhibition of bacterial biofilm buildâ€up and microbial reâ€colonization.But use of chlorhexidine mouthwash  may also lead to adverse effects such as  tooth staining, altered taste sensation, mucosal irritation. This reduces patient compliance towards the use of Chlorhexidine mouthwashes. To reduce the adverse effects and improve anti microbial efficacy, several components have been added to chlorhexidine mouthwash. Of that, a plasdone added mouthwash is being marketed as chlorhexidine mouthwash with Anti-Discoloartion System (Clohex ADS). However, there is no scientific evidence regarding evaluation of this mouthwash in prevention of tooth staining. Hence, this study was designed to comparatively evaluate the anti-staining effect of Chlorhexidine mouthwash with and without anti-discoloration system. This study will be conducted as a multi centric tripleâ€blinded, parallel study among Institutionalized old-age adults. The old age home people will be subjected for clinical examination. Participants meeting the inclusion criteria will be recruited into the study. All the selected participants will undergo complete ultrasonic scaling. In the same session, when professional oral hygiene was completed (T0), clinical indices such as Silness and Loe Plaque Index (1964) Gingival Bleeding Index (GBI—Ainamo Bay), Extrinsic Stain Index (Loebner), Intraoral digital photographs will be recorded for each patient. The participants will be randomly allocated to interventional groups GROUP I: Chlorhexdine Mouthwash Brand Name: Clohex Mouthwash (Dr.Reddy’s Laboratories) *Ingredients: Chlorhexidine 0.20 %*GROUP II: Chlorhexidine Mouthwash with Anti-Discoloration System Brand Name: Clohex ADS (Dr.Reddy’s Laboratories) *Ingredients: Chlorhexidine 0.20 %, Sodium Fluoride 0.05%, Zinc chloride 0.09%.*A standard tooth brush (soft) and toothpaste will be provided to all participants. The participants will be asked to rinse their mouth with 10 ml of mouthwash twice daily for 1 minute. Silness and Loe Plaque Index(1964), Gingival Bleeding Index (GBI—Ainamo Bay), Extrinsic Stain Index (Loebner), intraoral digital photographs will be recorded at 15th day. The plaque levels, gingival bleeding and tooth staining will be compared between the two interventional groups. Patients’s perception towards the use of mouthwash will be recorded using a questionnaire. This study has certain benefits to the study participants.Tooth brushing is quite difficult for institutionalized geriatric population due to their limited manual dexterity. Tooth brushing alone can’t eliminate all the plaque from teeth. Hence, mouthwash use as an adjunctive oral hygiene aid, can bring down the plaque levels and improve the periodontal status of the participants. As well as, the mouthwash with least adverse effect can be evaluated through this trial and can be recommended to bed ridden, physically challenged and geriatric people. Hence, this study results has potential to extend it’s implications to the general population.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Participants aged more than 60 years of age.
  • •Participants who are able to perform tooth brushing and mouth rinsing on their own.
  • •Participants who are classified as Periodontitis stage II, III or stage IV according to classification of Tonetti, Greenwell, & Kornman, 2018 4.Participants with intact upper and lower anteriors.
  • •Participants willing to participate in the study.

排除标准

  • •1.Participants with missing of more than two upper and lower anteriors.
  • •2.Participants with fixed partial dentures in upper and lower anteriors.
  • •3.Participants who consume any form of smoke or smokeless tobacco.
  • •4.Participants with psychological disorders.

结局指标

主要结局

To assess and compare the presence of extrinsic staining of teeth after the use of chlorhexidine mouthwashes with and without discoloration system.

时间窗: At baseline | 7 days, 15 days

次要结局

  • 1.To assess and compare the plaque content after the use of chlorhexidine mouthwashes with and without discoloration system(2.To assess and compare the presence of Gingival Bleeding after the use of chlorhexidine mouthwashes with and without discoloration system.)

研究者

发起方
Dr Karunanidhi K
申办方类型
Other [self]

研究点 (2)

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