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临床试验/NCT07840131
NCT07840131已完成不适用

Short-term Effects of Acacia Arabica Mouth Rinse and Paste on Plaque-induced Gingivitis

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Gingival Index (GI)

研究概览

简要总结

This randomized clinical pilot study evaluated the short-term effects of Acacia arabica mouth rinse and paste as adjuncts to conventional oral hygiene in adults with plaque-induced gingivitis. Thirty systemically healthy participants aged 18-42 years were randomly allocated into three groups: a control group receiving conventional oral hygiene measures, an Acacia arabica mouth rinse group, and an Acacia arabica paste group. All participants received professional plaque removal and standardized oral hygiene instructions at baseline. Participants in the intervention groups additionally used either the Acacia arabica mouth rinse or paste twice daily for four weeks. Clinical assessments were performed at baseline, 2 weeks, and 4 weeks. The study evaluated changes in plaque index, gingival index, bleeding on probing, and salivary pH. The study aimed to determine whether Acacia arabica formulations could provide additional short-term benefits in plaque and gingival inflammation control compared with conventional oral hygiene measures alone.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18-42 years.
  • •Diagnosis of plaque-induced gingivitis.
  • •Presence of gingival inflammation without clinical attachment loss or -radiographic evidence of alveolar bone loss.
  • •Presence of a minimum of 15 natural teeth per arch.
  • •Willingness to participate and provide written informed consent.

排除标准

  • •Systemic diseases or medical conditions that may affect periodontal health.
  • •Recent use of antibiotics or anti-inflammatory medications.
  • •Presence of fixed orthodontic appliances/wires.
  • •Current smoking.
  • •Pregnancy or lactation.
  • •Known allergy or hypersensitivity to herbal products.

研究组 & 干预措施

control

No Intervention

Participants received professional plaque removal at baseline and standardized oral hygiene instructions, including the modified Bass brushing technique. Participants were instructed to brush twice daily using a regular fluoridated toothpaste and received no Acacia arabica intervention during the 4-week study period.

Acacia arabica Mouth Rinse

Experimental

Participants received professional plaque removal and standardized oral hygiene instructions at baseline. In addition, participants used 10 mL of Acacia arabica mouth rinse, prepared at a concentration of 1 g of extract per 10 mL of distilled water, twice daily after toothbrushing for 4 weeks. Participants were instructed to swish the solution for 1 minute, retain it intraorally for an additional 2 minutes, and then expectorate.

干预措施: Acacia arabica Mouth Rinse (Other)

Acacia arabica Paste

Experimental

Participants received professional plaque removal and standardized oral hygiene instructions at baseline. In addition, participants applied a pea-sized amount of Acacia arabica paste (Gumtone® gel) to the gingiva twice daily after toothbrushing for 4 weeks. The paste was gently massaged into the gingiva for approximately 2 minutes and subsequently removed using gauze.

干预措施: acacia arabica paste (Other)

结局指标

主要结局

Change in Gingival Index (GI)

时间窗: Baseline, 2 weeks, and 4 weeks

Gingival inflammation was assessed using the Gingival Index at baseline, 2 weeks, and 4 weeks. The index was used to evaluate changes in the severity of gingival inflammation during the intervention period. Lower scores indicate less gingival inflammation and better gingival health.

Change in Plaque Index (PI)

时间窗: Baseline, 2 weeks, and 4 weeks

Plaque accumulation was assessed using the Plaque Index at baseline, 2 weeks, and 4 weeks. The index was used to quantify changes in dental plaque accumulation during the intervention period. Lower scores indicate less plaque accumulation and better plaque control.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elham Alsahafi

Associate Professor

Umm Al-Qura University

研究点 (1)

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