跳至主要内容
临床试验/NCT06575335
NCT06575335已完成不适用

Antibacterial Efficacy of Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies in Differently Abled Children- A Randomized Clinical Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Streptococcus mutans (S. mutans) count

研究概览

简要总结

This double-blind randomized clinical trial will be conducted among differently abled institutionalized children. Sixty participants aged 6-12 years with mild intellectual disability (ID) will be enrolled in the study and divided into two treatment groups. The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator. One group will receive triphala tooth wipes and the other will be given chlorhexidine tooth wipes, both for 7 days twice a day. Supragingival plaque sample will be collected from the buccal surface of the permanent maxillary first molar and will be subjected to microbial analysis for Streptococcus mutans (S. mutans) colonies using colony-forming units per millilitre (CFU/ml).

The tooth wipes will be prepared by the principal investigator under supervision of Pharmacognosist at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan.

详细描述

Preparation of Tooth Wipes:

Preparation of Triphala Tooth Wipes- The triphala decoction will be prepared by the principal investigator at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan under the supervision of Pharmacognocist. The three fruits of triphala will be bought in powder form from an ayurvedic drug vendor. A mixture will be made by combining equal proportion of all these three powders in distilled water. This will then be boiled till the volume reduces to 1/8th part of the initial volume.

A sweetener will be added to the decoction followed by filtering using a white muslin cloth and then storing in a sterile amber-coloured glass bottle in a refrigerator. This will preserve its organoleptic properties and its quality for fourteen days.

The decoction obtained will be subjected to dilution to obtain concentration. This will then be used to impregnate the marketed tooth wipes fabric. The triphala tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.

Preparation of Chlorhexidine Tooth Wipes- The commercially available chlorhexidine mouthwash containing will be purchased from the market and will then be used to impregnate the marketed tooth wipes fabric. The chlorhexidine tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

It will be a double-blinded study where the participants and the microbiologist will be unaware of the group allocation.

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants with informed consent
  • Children with mild intellectual disability as per American Association of Mental Deficiency (AAMD)
  • Age ranging from 6 to 12 years
  • One treatment group will be thirty children receiving triphala tooth wipes
  • The other treatment group will be thirty children receiving chlorhexidine tooth wipes

排除标准

  • Children who had received antibiotics within 3 months
  • Participants requiring urgent dental care during the period of study

结局指标

主要结局

Streptococcus mutans (S. mutans) count

时间窗: The S. mutans count will be assessed at baseline and at day 8 of the intervention.

Colony Forming Unit per millilitre (CFU/ml) classified as Class 0 (none), Class 1 (\<102), Class 2 (103-104) and Class 3 (10≥5) CFU/ml showing negligible, low, moderate and high caries susceptibility

次要结局

  • Plaque Index(These counts will be assessed at baseline and at day 8 of the intervention.)

研究者

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

Sana Masood

Principal Investigator

Dow University of Health Sciences

研究点 (1)

Loading locations...

相似试验