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临床试验/CTRI/2018/01/011495
CTRI/2018/01/011495已完成2/3 期

Efficacy of sugar free chewing gum containing casein phosphopeptide amorphous calcium phosphate (CPP-ACP) on demineralization around fixed orthodontic brackets - An in vivo study

Dr Shailaja R1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年10月2日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Vickers Hardness measurement of demineralized enamel around orthodontic brackets

研究概览

简要总结

This study is a randomized, double blind, parallel group,active controlled trial to evaluate the efficacy of sugarfree chewing gum with and without CPP-ACP in prevention of enameldemineralization around orthodontic brackets. The primary outcome measure is Vickers Hardness measurementof demineralized enamel around orthodontic brackets after 1 month use ofinterventional and control agents. The secondary outcome measure isto measure the VAS pain score due tochewing the gum in interventional groups in the first week and toidentify the number of appliance breakages in one month. The data were analysedstatistically. The results of this study showed that sugar-free gum containing CPP-ACP issuperior to an equivalent gum not containing CPP-ACP in prevention andremineralization of enamel demineralization. VAS pain scores betweenintervention and control groups showed statistically significant difference inthe pain perceived during the second day after separator placement andfirst day of activation of the arch wire. There is no statistical significancein the pain perceived during other days. There were no incidences of appliance breakage (debonding of brackets ordisplacement of arch wire) in gum chewing groups and control group over theperiod of 30 days.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
14.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • The criteria for including participants were no active caries lesions, normal salivary flow rate (approximately 1.0 mL/min), and buffer capacity (6.7-7.7).
  • Sound Premolars.

排除标准

  • active carious lesions, periodontal or any other oral pathology Subjects under antibiotics or any medications that could alter the salivary flow, pH & buffering capacity Dental anomaly- eg.
  • enamel hypoplasia , fluorosis.
  • Premolars- Carious/ Restored / Non vital / Fractured.
  • Patient with known milk protein allergy.

结局指标

主要结局

Vickers Hardness measurement of demineralized enamel around orthodontic brackets

时间窗: one month

次要结局

  • Mean VAS pain score due to chewing gum(one week)
  • to identify the number of appliance breakages(one month.)

研究者

发起方
Dr Shailaja R
申办方类型
Other [self]

研究点 (1)

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