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临床试验/CTRI/2026/02/103514
CTRI/2026/02/103514尚未招募1 期

Effectiveness of different oral hygiene regimens on the reduction of halitosis in healthy young adults – a randomized clinical study.

Panineeya Mahavidyalaya Institute of Dental sciences and research centre1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年2月27日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Plaque Index

研究概览

简要总结

To evaluate and compare the effectiveness of tooth brushing, tongue scraping, mouthwash rinsing with 2% w/v chlorhexidine mouthwash, mouthwash rinsing with probiotic mouthwash on plaque scores, gingival scores, halitosis scores.

A double blinded parallel randomized clinical trial.

The study will be conducted among young adults, (aged 18–25 years) residing in one of the nongovernmental organizations (NGOs) in Hyderabad.

sample size is 84, with 21 in each group.

Subjects in the age group of 18-25years

With a minimum halitosis score of   >_2 according to Hali meter

With fair to poor gingival and plaque scores

Willing to participate in the study are included.

With history of Systemic conditions

Antibiotic therapy in the past 3 months

Acute sinusitis

Oral conditions like dental caries and Periodontal disease (pocket depth and CAL)

Underwent gingival or periodontal treatment in the past 3 months.

Subjects performing oral hygiene procedures other than brushing will be excluded from study.

All eligible subjects will be given oral and written information about the purpose of the study

Informed consent will be obtained from the study subjects. Ethical clearance obtained from the Institutional ethics committee

84 were randomly allocated into four groups with 21 in each group

Group I : Tooth brushing only using a toothbrush(medium) with fluoridated toothpaste (sodium fluoride –1000 ppm).

Group II: Tooth brushing (medium) and tongue scraping (Tongue cleaner)

Group III: Tooth brushing and tongue scraping (Tongue Cleaner); and use of mouthwash (CHX mouth rinse [0.2% w/v CHX gluconate solution)

Group IV: Tooth brushing, tongue scraping (Tongue Cleaner); and use of probiotic mouthwash.

Random allocation of study subjects in each group was performed using the lottery     method. The examiner and the study subjects will be blinded towards the allocation of participants.The group allocation and concealment of procedure will be carried out independently by a separate investigator not included in the study procedure

The following information will be collected from each subject.

The demographic details such as age, gender, and education.

Subjects will be assigned with the different oral hygiene regimens advised to follow for 14 days.

Examination will be done base line (1st day), 7th, 14th day to assess,

A) Plaque Index (PI) (Silness P and Loe H)

B) Gingival Index (GI) (Loe and Silness)

C) Halitosis score

Subjects allotted with the different groups will be given instructions for oral hygiene methods.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • with minimum halitosis score with fair to poor gingival and plaque score willing to participate in the study.

排除标准

  • with history of systemic conditions antibiotic therapy in the past 3 months acute sinusitis caries and periodontal disease underwent gingival or periodontal treatment in the past 3 months subjects performing oral hygiene procedures other than brushing.

结局指标

主要结局

Plaque Index

时间窗: Base line | 7th day | 14th day

Gingival Index

时间窗: Base line | 7th day | 14th day

Halitosis score

时间窗: Base line | 7th day | 14th day

次要结局

未报告次要终点

研究者

发起方
Panineeya Mahavidyalaya Institute of Dental sciences and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr PADMA REDDY

Panineeya Mahavidyalaya Institute of Dental sciences and research centre

研究点 (1)

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