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临床试验/CTRI/2024/11/076976
CTRI/2024/11/076976尚未招募1 期

Assessment of periodontal status and biocompatibility in orthodontic patients with and without adjunct chlorine dioxide mouthwash– a randomized controlled trial

S LOCHINI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11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
40
试验地点
1
主要终点
PLAQUE INDEX

研究概览

简要总结

Oral prophylaxis will be performed in the department of periodontics before starting the orthodontic treatment

Full mouth periodontal status will be recorded and swab will be  collected in the buccal mucosa with soft bristles and placed inside a buffer solution container which act a  transport medium for micronucleus examination.

CONTROL GROUP  patients will be instructed to use interdental brushes

TEST GROUP  Patients will be instructed to use interdental brushes and adjunct chlorine dioxide mouthwash for 2 weeks twice a day for 1minute

·       Periodontal examination and buccal swab will be collected from both groups at baseline 1 month and 3rd month for micronucleus test

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 Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Clinically healthy with no systemic illness Subjects with no previous history of orthodontic treatment.

排除标准

  • Subjects with syndromes and debilitating diseases Oral mucosal lesions Smokers and tobacco chewers Subjects with prosthesis or restorations.

结局指标

主要结局

PLAQUE INDEX

时间窗: BASELINE | 1 MONTH | 3RD MONTH

GINGIVAL BLEEDING INDEX

时间窗: BASELINE | 1 MONTH | 3RD MONTH

PROBING POCKET DEPTH

时间窗: BASELINE | 1 MONTH | 3RD MONTH

CLINICAL ATTACHMENT LEVEL

时间窗: BASELINE | 1 MONTH | 3RD MONTH

次要结局

  • MICRONUCLEUS TEST(BASELINE)

研究者

发起方
S LOCHINI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

S Lochini

SRM Kattankulathur dental college and Hospital

研究点 (1)

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