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临床试验/NCT07822256
NCT07822256已完成不适用

Comparing the Antiplaque Effects of Chlorhexidine Mouthwash and Essential Oil-Containing Mouthwash in Patients Reporting to Rehman College of Dentistry: A Randomized Clinical Trial

Rehman Medical Institute - RMI1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月3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
60
试验地点
1
主要终点
Change in Plaque Index Score

研究概览

简要总结

Dental plaque is a sticky film of bacteria that forms on teeth and can lead to gum disease if it is not removed regularly. Brushing and flossing help control plaque, but many people also use a mouthwash to help clean areas that are hard to reach.

This study compares two common types of mouthwash to see which one works better at reducing plaque: a mouthwash containing chlorhexidine (a medicated antibacterial ingredient) and a mouthwash containing essential oils (natural plant-based ingredients). Both are widely used, but they work in different ways and may cause different side effects.

Sixty patients between the ages of 15 and 25 who had gum inflammation (gingivitis) took part. Half of the patients used the chlorhexidine mouthwash twice a day, and the other half used the essential oil mouthwash twice a day, for three months. Researchers measured the amount of plaque on each patient's teeth at the start of the study and again after three months, using a standard scoring method. They also recorded how well patients stuck to the mouthwash routine and any side effects they experienced, such as changes in taste, staining of the teeth, or a burning feeling in the mouth.

The goal of this study is to help patients and dental care providers understand the benefits and drawbacks of each mouthwash, so they can choose the option that best fits their needs - whether that is stronger plaque control for a short period of time, or a milder option that may be more comfortable for longer-term use.

详细描述

Dental plaque is one of the main causes of gum inflammation and periodontal (gum) disease. While brushing and flossing remain the primary way to remove plaque, mechanical cleaning alone often cannot fully reach all tooth surfaces. As a result, chemical mouthwashes are commonly recommended as an additional way to control plaque.

Chlorhexidine gluconate mouthwash is considered one of the most effective plaque-control products because it kills a broad range of bacteria and stays active in the mouth for an extended period. However, longer-term use has been associated with side effects such as tooth staining and taste changes. Mouthwashes containing essential oils (plant-derived antibacterial ingredients such as thymol and menthol) are often used as a gentler alternative, though their plaque-reducing effect compared to chlorhexidine has varied across previous studies.

This randomized clinical trial was conducted at the Department of Periodontics, Rehman College of Dentistry, Peshawar, from February 2026 to August 2026. Sixty participants aged 15-25 years with gingivitis (gum inflammation without bone or attachment loss) were enrolled and divided into two equal groups of 30. Group I used a 0.2% chlorhexidine gluconate mouthwash twice daily, and Group II used an essential oil mouthwash twice daily, both for a period of three months. Participants were selected using a non-probability consecutive sampling method, and all received professional teeth cleaning (scaling and polishing) before starting the study, followed by a 10-day period to allow a consistent starting point for plaque measurement.

Plaque levels were measured using the Silness and Löe Plaque Index, a standard scoring method that assesses plaque on six specific teeth at the start of the study and again after three months. The dental examiner who scored the plaque levels was not told which mouthwash each participant had been using, to reduce bias in the assessment. All participants were given the same basic oral hygiene instructions (brushing twice daily), so that any difference in outcomes could be more clearly linked to the mouthwash itself.

Researchers compared plaque scores, percentage reduction in plaque, participant compliance with the assigned mouthwash routine, and any reported side effects between the two groups. Statistical methods included ANCOVA to compare three-month plaque scores while accounting for each participant's starting plaque level, along with t-tests and chi-square tests for other comparisons.

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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 15-25 years
  • Diagnosis of gingivitis (inflammatory condition of the gums without attachment or bone loss)
  • Willingness to provide written informed consent (or parental/guardian consent plus assent, for minors)

排除标准

  • Periodontitis
  • Known allergy or hypersensitivity to chlorhexidine
  • Any systemic disease that could affect periodontal health
  • Current antibiotic therapy
  • Presence of anterior composite restorations
  • Visible enamel decalcification

研究组 & 干预措施

Essential Oil Mouthwash Group

Experimental

Participants (n=30) used an essential oil-containing mouthwash twice daily for three months. Participants were instructed not to swallow the mouthwash and not to rinse their mouth with water after gargling. All participants also received standard oral hygiene instructions, including brushing twice daily with a toothbrush and toothpaste.

干预措施: Essential Oil mouthwash (Drug)

Chlorhexidine Mouthwash Group

Active Comparator

Participants (n=30) used a 0.2% chlorhexidine gluconate mouthwash, gargling twice daily for 30 seconds, for a period of three months. All participants also received standard oral hygiene instructions, including brushing twice daily with a toothbrush and toothpaste.

干预措施: Chlorhexidine Gluconate Mouthwash (Drug)

结局指标

主要结局

Change in Plaque Index Score

时间窗: Baseline and 3 months

Dental plaque was measured using the Silness and Löe Plaque Index on six selected teeth (16, 11, 26, 36, 31, and 46), scoring each tooth's distal, buccal, mesial, and lingual/palatal surfaces from 0 (no plaque) to 3 (abundant plaque in the gingival sulcus or margin).

次要结局

  • Percentage Reduction in Plaque Index(Baseline to 3 months)
  • Incidence of Adverse Events(3 months)

研究者

发起方
Rehman Medical Institute - RMI
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aimen Ishtiaq

PG Trainee

Rehman Medical Institute - RMI

研究点 (1)

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