跳至主要内容
临床试验/NCT03285360
NCT03285360已完成1 期

Effectiveness of Sylc Air Abrasion Bioactive Glass Technology Versus Fluoride Varnish Application in Management of Hypersensitivity of Non-Carious Cervical Lesions: Randomized Clinical Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Pain due to dentin hypersensitivity (evaporative stimulus)

研究概览

简要总结

Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride Varnish (Biflourid 10) affects the degree of pain in patients complaining from hypersensitivity due to non-carious lesions?

详细描述

  • Population: Patients complaining from Dentin Hypersensitivity due to non-carious lesions.
  • Intervention: Sylc, Air Abrasion Bioactive glass (Denfotex Research Ltd.)
  • Comparison: BiFlourid 10, Fluoride Varnish (VOCO, Germany)
  • Outcome measures: Dentin Hypersensitivity

Outcome name Measuring device Measuring unit Dentin Hypersensitivity

  • Thermal
  • Tactile
  • Evaporative

研究设计

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

盲法说明

double blinded

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females.
  • Age: 18-70 years old.
  • Patients with good oral hygiene.
  • Co-operative patients who show interest to participate in the study.

排除标准

  • Patients with bad oral hygiene.
  • Patients with orthodontic appliances, or bridge work that might interfere with evaluation.
  • Patients who did any periodontal surgeries within the previous 6 months.
  • Patients who are allergic to any ingredients will be used in the study.
  • Pregnant and lactating women.

研究组 & 干预措施

sylc bioactive glass

Experimental

Sylc is a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment.

Steps:

  1. Isolation: D.M. will make proper isolation for the teeth using cotton rolls.
  2. Hand piece: NSK Prophymate Neo will be used to deliver the powder particles on the sensitive areas. Air stream adjusted at 40-46 psi.
  3. Application: The hand piece will be held at constant distance (3-4mm) away from the tooth surface, with 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth in a circular movement.
  4. Suction: High volume suction will be used on lingual side of the teeth to suck any particles, and avoid patient from swallowing it.

干预措施: Sylc (Combination Product)

fluoride varnish (Bifluorid 10)

Active Comparator

fluoride varnish Bifluorid 10(by VOCO) will be used. It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.

The single dose form will be used, to make sure the amount of fluoride varnish used is standardized.

Steps:

  1. Preparation: The tooth will be properly cleaned, and the surface will be air-dried.
  2. Dispensing: The foil will be pierced using a micro- tim, the opening will be enlarged, the brush will be wet in a circular movement.
  3. Application: Thin coat will be applied on the tooth surface. The varnish will be left from 10-20 seconds then air dried.

Concerning the storage of the Bifluoride 10, it will be stored in refrigerator at the operative clinic to avoid exposure to high temperature or sunlight.

干预措施: fluoride varnish (Bifluorid 10) (Combination Product)

结局指标

主要结局

Pain due to dentin hypersensitivity (evaporative stimulus)

时间窗: 2 minutes after treatment

Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS

次要结局

  • Pain due to dentin hypersensitivity (tactile stimulus)(12 months)
  • Pain due to dentin hypersensitivity (thermal stimulus)(12 months)
  • Pain due to dentin hypersensitivity (evaporative stimulus)(12 months)

研究者

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

Dina Ezz

Principal investigator

Cairo University

研究点 (1)

Loading locations...

相似试验