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临床试验/CTRI/2025/02/080132
CTRI/2025/02/080132尚未招募2 期

Comparative evaluation of antimicrobial activity of Plum seed extract mouthwash against streptococcus mutans and Lactobacillus acidophillus in patients undergoing fixed orthodontic treatment - A randomised controlled clinical trial

未提供1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
116
试验地点
1
主要终点
Streptococcus mutans and Lactobacillus acidophilus count in dental plaque of patients belonging to the four study groups

研究概览

简要总结

The study aims to evaluate and compare the antimicrobial activity of 2% and 5% plum seed extract mouthwash with 0.12% chlorhexidine mouthwash and a control group without mouthwash against Streptococcus mutans and Lactobacillus acidophilus in the dental plaque of patients undergoing fixed orthodontic treatment. Patients aged over 18 years, enrolled for fixed orthodontic treatment without therapeutic extractions, and meeting the inclusion criteria, will be randomly assigned to the four study groups using a computer-generated random chart with allocation concealment through sealed envelopes. Inclusion criteria include patients with a full complement of permanent teeth (excluding third molars), a DMFT score not exceeding 2, a gingival index (Löe) score of less than 1, and those undergoing treatment with 0.022-inch slot MBT prescription stainless steel orthodontic brackets (Mini Diamond, Ormco Corporation, California, USA), with initial archwires tied to the bracket slots using elastomeric ligatures. Participants must also be willing to provide informed consent. Exclusion criteria include smoking habits, current antibiotic therapy, and systemic diseases. Plum seed extract mouthwash will be prepared following established protocols in the literature, while the 0.12% chlorhexidine mouthwash (Perioguard, Colgate Palmolive, India) will be procured without any additional antimicrobial agents. All patients will undergo oral prophylaxis before appliance bonding and will receive uniform oral hygiene and diet instructions. Each patient will be provided with a medium-texture orthodontic toothbrush and non-fluoridated, non-medicated toothpaste, with instructions to brush twice daily for at least three minutes. Group I will use 2% plum seed extract mouthwash, Group II will use 5% plum seed extract mouthwash, Group III will use 0.12% chlorhexidine mouthwash, and Group IV will serve as the control without any mouthwash instructions. A compliance chart will be provided to all patients, who will document mouthwash use, and the chart will be reviewed at each visit. Samples will be collected at 1, 3, and 6 months post-appliance bonding. Supra-gingival plaque samples will be collected from the right lateral incisor using a 4-pass technique during early morning appointments, with patients instructed not to brush their teeth on the day of collection. These samples will be transferred to vials containing appropriate media, transported to the laboratory, and evaluated for Streptococcus mutans and Lactobacillus acidophilus counts. Colony counts will be measured using a colony counter, and the results will be expressed in CFU/mL.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patients with full complement of teeth in permanent dentition (excluding third molars) DMFT score nor greater than 2 Gingival index (Loe ) score less than 1 Will undergo treatment with 022” slot MBT prescription stainless steel orthodontic brackets (Mini diamond, Ormco corporation, California, USA) with initial archwires tied to the bracket slots with elastomeric ligatures Who are willing to give informed consent to participate in the study.

排除标准

  • Smoking habit , patients under antibiotic therapy Systemic disease.

结局指标

主要结局

Streptococcus mutans and Lactobacillus acidophilus count in dental plaque of patients belonging to the four study groups

时间窗: 1st month,3rd month,6th month after the beginning fixed appliance treatment

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

KAVALI STANLEY

SRM Dental College

研究点 (1)

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