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临床试验/NCT05650840
NCT05650840尚未招募不适用

Enamel Abrasion and Stain Removal Efficacy of Charcoal -Based and Calcium Carbonate /Perlite Whitening Toothpastes: A Randomized Clinical Trial and In-vitro Trial

Cairo University0 个研究点目标入组 38 人开始时间: 2023年1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
尚未招募
入组人数
38
主要终点
Stain scores as per Macpherson modification of the Lobene stain index

研究概览

简要总结

The aim of the study is to clinically evaluate the efficacy of external stain removal of an activated charcoal based tooth paste versus calcium carbonate /perlite tooth paste. Additionally, to investigate enamel surface abrasion for both toothpastes in vitro.

详细描述

Statement of the problem:

Access to in-office treatments is restricted to a lot of population. Therefore, there has been an interest in developing methods so that patients can remove stains and apply tooth whitening at home. Accordingly, toothpastes, due to their ease of use and low cost, have been used as vehicles for whitening agents as an alternative to home/office whitening.

Hydrogen peroxide is the most commonly used agent for whitening teeth, which is used in various concentrations according to various techniques at home and office. Bleaching of teeth in office is done at a high concentration of Hydrogen peroxide for a specified period of time. In addition to conventional whitening treatments, over-the-counter products, including gels, toothpastes, bleaching strips, mouthwashes, and pens with different Hydrogen peroxide levels, have been developed. In-office teeth whitening is one of the more costly forms of teeth whitening and the concentration of the bleaching element is higher, it is better monitored by a professional.

Whitening toothpaste is probably the one of the most affordable options for someone looking to whiten their teeth at home, which contain abrasive and chemical agents and have the ability to remove external stains from the tooth. The abrasiveness of toothpastes depends on the hardness, size, and shape of abrasive particles. Furthermore, factors such as the brushing technique, brushing pressure, toothbrush hardness, and the number of brush strokes affect tooth abrasion. Abrasive agents include silica, phosphates, carbonates, and bicarbonates. Chemical agents present in whitening toothpastes are sodium citrate, phosphate salt. which react with chromogenic molecules of superficial dental stains and eliminate them from the tooth surface.

Whitening toothpastes include different active ingredients in their composition. It normally contain a higher amount of abrasives and detergents than do conventional toothpastes. In this sense, it is important to point out that toothpastes with higher amounts of abrasives may produce increased surface roughness in dental tissues, or restorations, or even tooth sensitivity, especially if they are used routinely.

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

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients inclusion:
  • •Adult male and female patients ≥18 years.
  • •Good oral and general health and oral hygiene have at least eight natural anterior teeth (incisors and canines) assessable for extrinsic stain and be available for all study appointments.
  • •Patients exclusion:
  • •Uncooperative behavior.
  • •Patients allergic to tooth paste material.
  • •Patient with history of medical disease, drug therapies or any other serious relevant problem.
  • •Pregnant or breastfeeding women.
  • •Patients with fixed orthodontic appliances
  • •Patients who had professional tooth whitening, within the last six months.
  • •Patients who had significant amounts of calculus on facial surfaces of the incisors/canines.
  • •Patients who had undergone professional periodontal treatment within the previous six months or used mouth rinses for the treatment/ control of a periodontal condition.
  • •Patients who had advanced periodontal disease on anterior teeth.
  • •Xerostomic patients.
  • •Patients who used medications which could affect saliva flow or cause staining.
  • •Patients who had undergone dental prophylaxis within 8 weeks of screening.
  • •Patients who used minocycline or doxycycline within 30 days of screening or between screening and baseline.
  • •Tooth inclusion:
  • •▪ Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.
  • •Tooth exclusion:
  • •Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment).
  • •Restorations in anterior teeth, parafunctional habits or tooth sensitivity.
  • •Non- vital teeth.
  • •Teeth inclusion criteria:
  • •Intact, free of caries or restorations.
  • •No cervical lesions

排除标准

  • •Intrinsically Discolored teeth caused by tetracycline, fluorosis, hyperplasia, endodontic treatment .
  • •Restorations in teeth.

研究组 & 干预措施

Charcoal -based whitening toothpaste

Experimental

signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt

干预措施: Charcoal based whitening toothpaste (signal charcoal white& Detox toothpaste Unilever Mashreq - Egypt (Procedure)

Calcium carbonate /perlite containing whitening toothpaste

Active Comparator

signal whitening moonlight toothpaste Unilever Mashreq - Egypt

干预措施: Calcium carbonate /perlite containing whitening toothpaste (signal whitening moonlight toothpaste Unilever Mashreq - Egypt). (Procedure)

结局指标

主要结局

Stain scores as per Macpherson modification of the Lobene stain index

时间窗: after four weeks

Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration 1. faint stain 2. clearly visible stain, orange to brown (moderate stain) 3. dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: 1. thin line, can be continuous (\< 1/3) 2. thick line or band (\>1/3, \<2/3) 3. covering total area (\> 2/3)

Stain scores as per Macpherson modification of the Lobene stain index

时间窗: Baseline

Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration 1. faint stain 2. clearly visible stain, orange to brown (moderate stain) 3. dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: 1. thin line, can be continuous (\< 1/3) 2. thick line or band (\>1/3, \<2/3) 3. covering total area (\> 2/3)

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

Mohamed Osama Metwally

Master student, conservative department, faculty of dentistry

Cairo University

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