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临床试验/NCT06829277
NCT06829277已完成不适用

Efficacy of Biomimetic Mineralization Approach Plus Soft Laser Irradiation in Management of Dentin Hypersensitivity: A Randomized Clinical Trial

MTI University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Dentin hypersensitivity

研究概览

简要总结

Randomized clinical trial to investigate the efficacy of diode laser , Biomimetic mineralization desensitizing agents Curodont D'Senz (CS) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. Also, to assess the duration of sensitivity relief immediately after 15 minutes of application, after 2 weeks, after 1 month and 3 months , the null hypothesis that there will be no difference between the treatment groups in different times.

详细描述

Current research focuses on increasing the mineral density of the dentin surface making it possible to improve its resistance to wear by both acid erosion and abrasion and plugging and sealing open tubules with a calcium and phosphate containing dentin-like substance, which would block diffusion through the tubules into the dentin sub-surface, thereby increasing acid resistance. Self-assembling peptide matrix (P11-4) supplied commercially as Curodont D'Senz (CS) gel (Credentis AG, Windisch, Switzerland) is based on the nanofiber technology that enhances biomimetic repair and the remineralization of dental tissues. Self-assembling peptide matrix hydrogel revealed more reduction of the opened dentinal tubules in comparison to other selected desensitizing toothpaste.lasers have been recently been introduced as another possibility for in-office treatment of DH and may open up new horizons in the treatment of dentin hypersensitivity. Of interest is the fact that the laser irradiation can augment the effect of the desensitizer for a longer duration than when they are used alone. They hypothesized that laser favor the durability of the desensitizer for extended time. Some studies recommend desensitizing agent to remain above tooth surface for one minute before laser irradiation.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Age from 18-60 years old.
  • •Non-smokers.
  • •Disease-free patients.
  • •Good oral hygiene.
  • •Having at least one teeth suffering from cervical dentin hypersensitivity with VAS pain score ≥5
  • •Recording pain to thermal, mechanical or tactile stimuli.
  • •Acceptance to participate in the study

排除标准

  • •Smoking and bad oral hygiene.
  • •Presence of carious lesions, restorations or fracture in the test area.
  • •Presence of painful pathology restored less than three months in the test area.
  • •Using any desen¬sitizing agents.
  • •Undergo any peri¬odontal surgery in the last 6 months.
  • •Drug abusers.
  • •Administration of potent analgesics or anti-inflammatory drugs.

研究组 & 干预措施

Curodont De senz

Experimental

Curodont De Senz

干预措施: Curodont De Senz (Other)

Curodont De Senz plus laser irradiation

Experimental

Curodont De Senz plus laser irradiation

干预措施: Curodont De Senz plus laser irradiation (Combination Product)

Sodium fluoride varnish

Active Comparator

Sodium fluoride varnish

干预措施: Sodium fluoride varnish (Combination Product)

Laser irradiation

Experimental

Laser irradiation

干预措施: Laser irradiation (Device)

结局指标

主要结局

Dentin hypersensitivity

时间窗: Baseline - 15 minutes- 2 weeks - 1 month - 3 months

Visual Analogue Scale (VAS) will be used by which 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity. The VAS scale (0-10) is the recommended tool used to evaluate pain of dentin hypersensitivity, and it is the most commonly used in most of the clinical trials. The patient should point out the degree of sensitivity on the VAS scale (0-chart the degree of pain. (VAS \>4). A plastic card with figures of facial expressions expressing the degree of pain, color-coded, and numbers guided will be used to ease the process of figuring out the degree of pain. These cards are also useful in standardizing the assessment method for the patient throughout the study and taking records without any verbal or emotional guidance from the assessors.

A- Tactile test

时间窗: Baseline - 15 minutes- 2 weeks - 1 month - 3 months

By explorer

B- Evaporative test

时间窗: Baseline - 15 minutes - 2 weeks- 1 month - 3 months

By air syringe

C- Thermal Test

时间窗: Baseline - 15 minutes - 2 weeks- 1 month - 3 months

By refreigent spray

次要结局

未报告次要终点

研究者

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

Mennatallah Atef Aboulnaga

Lecturer in operative dentistry

MTI University

研究点 (1)

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