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临床试验/CTRI/2024/03/064772
CTRI/2024/03/064772进行中(未招募)2 期

Comparative Evaluation of Effectiveness of At-Home Dental Bleaching Using Different Concentrations Of Carbamide Peroxide for Different Time Intervals: A Randomized Clinical Trial

DR ZIAUDDIN AHMAD DENTAL COLLEGE AMU ALIGARH1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年4月2日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
84
试验地点
1
主要终点
Evaluate effectiveness of three different concentrations(10%, 22%, 35%) of carbamide peroxide with reduced application time for at-home bleaching in terms of colour change.

研究概览

简要总结

Treatment Protocol:

Two weeks prior to the bleaching procedure, calculus or plaque deposits will be removed using ultrasonic scaler. Buccal/labial surfaces of teeth will be polished using prophylaxis paste and polishing cup fitted on a low-speed hand piece. All participants will be advised to brush their teeth twice a day using toothpaste not containing any bleaching compound within its ingredients throughout the study period. Baseline shades will be recorded for each patient using Vita classical shade guide and Vita bleach guide 3D MASTER in shade guide units. Shade measurements will be recorded for the middle third of labial surfaces of each maxillary anterior teeth.  Alginate impression of both the arches of each participant will be obtained to prepare stone molds and trays will be fabricated for both the arches. Trays will be properly trimmed, 2 mm from the gingival margin and will be tested in patient and adjusted as needed.

Application of the bleaching material will be demonstrated to each participants. Participants will be instructed to use the tray holding the respective concentration of carbamide peroxide for the specified time intervals according to the groups in which they will be allocated.  Each treatment will be performed for 3 weeks. Participants will be instructed to fill out the Visual analogue scale form daily throughout the treatment given to them at beginning of the treatment. The color evaluation will be repeated and recorded at the end of first, second and third week and a month after a treatment’s conclusion.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Vital teeth free from carious and non-carious lesions in maxillary anterior lacking periodontal diseases.
  • Minimum baseline shade A2.

排除标准

  • Previous history of tooth sensitivity.
  • Previous dental whitening treatment.
  • Serious dental discoloration.
  • Visible cracks.
  • Pregnant and breast-feeding females.

结局指标

主要结局

Evaluate effectiveness of three different concentrations(10%, 22%, 35%) of carbamide peroxide with reduced application time for at-home bleaching in terms of colour change.

时间窗: 1st week, 2nd week, 3rd week, 1 month after 3rd week.

次要结局

  • evaluate tooth sensitivity caused by carbamide peroxide gel ( 10%, 22% & 35%)(Day 1 to Day 21)

研究者

发起方
DR ZIAUDDIN AHMAD DENTAL COLLEGE AMU ALIGARH
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nandani Kumari

Aligarh Muslim University

研究点 (1)

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