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临床试验/NCT03309748
NCT03309748已完成不适用

Remediation of Adult Black Dental Stains by Phototherapy

Cardenal Herrera University0 个研究点目标入组 31 人开始时间: 2014年5月5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
发起方
入组人数
31
主要终点
Restoration period

研究概览

简要总结

This study investigates the remediation of black-stained tooth surfaces using antimicrobial photodynamic therapy. In this crossover trial, a cohort of patients received standard dental prophylactic cleaning to remove the black stain. Later, following the washout period, (reappearance of the black stain) received photodynamic therapy in addition to the standard cleaning. Stain-free period in each of the arms was the main outcome variable. Additional microbial plaque testing was also carried out.

详细描述

The standard treatment practice for black dental stain is dental prophylaxis, however this is often harmful to the enamel surface and can result in tooth sensitivity. In this study we aim to explore the application of antimicrobial photodynamic therapy (aPDT) for the treatment of adult black dental stain. aPDT has demonstrated positive results in the treatment of periodontitis.

Patients received an oral examination and the extent of black stain was scored (score 1, pigmented spots or incomplete lines parallel to the gingival margin, score 2: solid lines pigmented, readily observable and limited to the cervical third of the tooth surface, score 3: pigmentation extending beyond the cervical third). The patients' oral cavity was photographed in sextants, along with a complete picture of the jaw (lingual plane) and the maxillary arch (palatal plane). For bacterial analysis, 1mg of black plaque was collected by scraping with a plastic scaler from buccal tooth surfaces taking care to avoid unnecessary removal of enamel hydroxyapatite. The first dental prophylaxis was performed to remove the black stain.

Patients were reviewed monthly and in each visit, were photographed as previously described, and the level of pigmentation scored according to the mentioned criteria. The monthly visits were continued until the black stain score returned to the initial value. The period between the first and the last appointment was noted. At this point, each volunteer received dental prophylaxis once again, followed by the application of aPDT. Antimicrobial photodynamic therapy was applied to 31 orally healthy volunteers with black stained teeth, using the GLO home whitening device (GLO™ Science LLC, New York, USA) in 2 cycles of 8 minutes. Outcome variables were area, color and time taken to reappearance of black stain following dental prophylaxis with and without antimicrobial photodynamic therapy. Differences in bacterial composition of black stain (specifically Aggregatibacter actinomycetemcomitans, Tannerella forsythia and Porphyromonas gingivalis) were analyzed DNA extracted from plaque samples. Following the application of aPDT, patients were reviewed monthly until the black stain score returned to the initial value.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Volunteers with black stained (plaque on) teeth

排除标准

  • Pregnant women
  • Volunteers having completed antibiotic therapy during 15 days prior to the start of the study

研究组 & 干预措施

Dental Prophylaxis

Active Comparator

Standard dental prophylaxis

干预措施: Dental prophylaxis (Procedure)

Dental prophylaxis + antimicrobial photodynamic therapy

Active Comparator

Dental prophylaxis + aPDT

干预措施: Dental prophylaxis (Procedure)

Dental prophylaxis + antimicrobial photodynamic therapy

Active Comparator

Dental prophylaxis + aPDT

干预措施: Dental prophylaxis + antimicrobial photodynamic therapy (Device)

结局指标

主要结局

Restoration period

时间窗: The period of time required for the restoration of the black stain to pre-cleaning levels will be determined by measurements carried out during Weeks 18-24, post-application of each treatment arm

Time to restoration of the black stain following each treatment arm

次要结局

  • Black stain area(Area covered by the black stain will be carried out at Week 20 following the application of each treatment arm)
  • Black stain color(The depth of color of the black stain will be measured at Week 20 following the application of each treatment arm)
  • Microbial composition(Black plaque sampling will be carried out at Week 0, followed by a second sampling at Week 20, following the application of each treatment arm, in accordance with the reappearance rate of the black stain in each study volunteer)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chirag Sheth

Associate Professor

Cardenal Herrera University

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