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临床试验/CTRI/2018/01/011303
CTRI/2018/01/011303已完成不适用

Comparative Clinical Evaluation of the Efficacy of a SingleTopical Application of Potassium Oxalate Desensitising Solution (Super Seal®) VsFluoride Varnish (Fluor Protector N) on Dentinal Hypersensitivity: an In Vivo and InVitro study

Parkavi A1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
visual analogue score of pain

研究概览

简要总结

This is a split mouth, single bllind, interventional, case control study. The aim of the study is to evaluate and compare in vitro and in vivo the efficacy of a single topical application of Potassium Oxalate Desensitising Solution (Super SealR) Vs Fluoride varnish (Fluor Protector N) on dentinal hypersensitivity. 50 patients with the chief complaint of dentinal hypersensitivity with atleast one hypersensitive teeth on contralateral side of the arch with visual analogue score of 3 or more will be enrolled in the study after oral prophylaxis and baseline examination. sensitive teeth on the right side of the arch will be treated with a single topical application of Potassium Oxalate Desensitising Solution (Super SealR) and the sensitive teeth on the left side of the arch will be treated with a single topical application of Fluoride varnish (Fluor Protector N). the patients will be evaluated for sensitivity using visual analogue scale postoperatively at one week and four weeks. In vitro study will be done on human extracted teeth sections using SEM analysis.

RESULT:

IN VIVO STUDY: RESPONSE TO WATER: 1 week post treatment , reduction in dentinal sensitivity to water stimulus by Potassium Oxalate Desensitising Solution (Super SealR) was significantly better than Fluoride varnish (Fluor Protector N) and the reduction in dentinal sensitivity to water stimulus 1 month post treatment between Potassium Oxalate Desensitising Solution (Super SealR) and Fluoride varnish (Fluor Protector N) was not significantly different and both were found to be equal.

IN VIVO STUDY - RESPONSE TO AIR - 1 week post treatment, reduction in dentinal sensitivity to air stimulus by Potassium Oxalate Desensitising Solution (Super SealR) was significantly better than Fluoride varnish (Fluor Protector N) and the reduction in dentinal sensitivity 1 month post treatment to air stimulus between Potassium Oxalate Desensitising Solution (Super SealR) and Fluoride varnish was not significantly different and both were equal.

IN VITRO STUDY - After treatment the dentinal tubule occlusion of both the solutions were found to be equal.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients in good systemic health
  • Self complaint of dentinal hypersensitivity following a cold stimuli such as ice cream, iced drink, or a rapid jet of cool air to a particular tooth or teeth
  • The patients ranged in age from 20 to 60 years
  • Patients with at least one sensitive tooth on contralateral sides with a VAS score of ≥3
  • Patients with gingival recession having dentinal hypersensitivity
  • Patients with vital teeth
  • Patients with a minimum of 10 teeth in their total dentition
  • Cooperative patients who can be motivated to maintain good oral hygiene.

排除标准

  • Previous treatment for hypersensitivity within the last six months
  • Restorative work performed on the hypersensitive teeth within the last 6 months
  • Topical fluoride treatment within the last 6 months
  • Periodontal surgery or root planing on the hypersensitive tooth within the last 6 months.
  • Known allergy to Potassium oxalate or Fluoride or any other drug allergy
  • Large carious lesions or cracked tooth structure
  • Patients with orthodontic appliance, crowns, bridges in the area of sensitivity.
  • Previous endodontic treatment on the selected teeth.
  • Pregnant and/or lactating mothers.
  • Patients with any bleeding disorders.

结局指标

主要结局

visual analogue score of pain

时间窗: at baseline, one week post-application and 4 weeks post application.

次要结局

  • tubular occlusion(1, 3 , 5 ,7, 10 days)

研究者

发起方
Parkavi A
申办方类型
Other [self-sponsored by primary investigator]

研究点 (1)

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