Effect on Periodontal Markers Interleukin-RANK by Walking Bleaching Non-Vital Technique: Clinical Randomized Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Bone destruction markers in gingival fluids
研究概览
简要总结
OBJECTIVES: The aim of this clinical randomized, double-blind clinical study was to assess the markers levels of RANKL IL-1B and OPGL, involved in the external cervical resorption as a primary outcome, and change color effectiveness in patients undergoing intracoronary bleaching.
METHOD: 46 volunteers (50 teeth) participated with discoloration on non-vital teeth, with the endodontic treatment in good condition. Patients were randomly located into two study groups according to product G1 = 35% hydrogen peroxide (n = 25) and G2 = 37% carbamide peroxide (n = 25).
The intracameral bleaching was performed with a walking bleaching technique of 4 sessions Gingivocrevicular transudate samples were taken to determine levels of Il1b, RANKL, and OPGL with absorbent paper (Periopaper®), they are obtained from six sites per tooth bleaching: 3 vestibular and three palatine (mesial, middle and distal), in 6 opportunities:
Baseline, after 4-sessions of intracameral bleaching and a one week after treatment. Total proteins are quantified by Bradford ® system and from the eluted sample of RANKL, IL 1b and OPGL levels measured by ELISA (Quantikine®; R&D Systems Inc.).
The color was evaluated in each session with Vita EasyShade spectrophotometer is used with the CIEL*a*b system to measure the total variation in color (ΔE), between the baseline and the different evaluation times.
详细描述
The trial was randomized and double-blind (patient and operator). Advertising was held to invite participation in dental school and through social networks like Facebook or Twitter.
Sample size
To determine the size of the sample GPower 3.1 software was used, considering a significance level of 5% statistical power of 80%.
A total of 74 patients were examined to assess whether they met the criteria for inclusion and exclusion. Patients: over 18 years, with one or more non-vital teeth, the restoration does not cover the vestibular face, endodontic treatment is in good condition, without apical lesion, with no previous experience of tooth whitening and tooth shade A2 or greater according to the Vita Classical scale. Patients were excluded pregnant or lactating, patients with enamel hypoplasia, with teeth stained by tetracycline or fluorosis, in orthodontic treatment with fixed appliances, patients with cancer or periodontal diseases. In addition to those volunteers to be examined clinically and radiographically present caries, periapical lesions, external or internal dental resorption and / or periodontal disease, as may be informed and referred to specialists for treatment.
46 patients, of whom 44 completed treatment and attended all controls were selected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over 18 years,
- •with one or more non-vital teeth,
- •the restoration does not cover the vestibular face of teeth,
- •endodontic treatment is in good condition, without apical lesion,
- •with no previous experience of tooth whitening and tooth shade A2 or greater according to the Vita Classical scale.
排除标准
- •excluded pregnant or lactating,
- •patients with enamel hypoplasia,
- •with teeth stained by tetracycline or fluorosis,
- •in orthodontic treatment with fixed appliances,
- •patients with cancer or periodontal diseases.
研究组 & 干预措施
PH
Hydrogen peroxide 35% to intracoronal bleaching in discoloration teeth eith endodontic treatment
干预措施: Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA) (Other)
PC
Carbamide peroxide 37% to intracoronal bleaching in discoloration teeth eith endodontic treatment
干预措施: carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil). (Other)
结局指标
主要结局
Bone destruction markers in gingival fluids
时间窗: 1 year
\[Interleukin 1b , RANK-L, OPG \] (pg/ml)
次要结局
未报告次要终点
研究者
Eduardo Fernandez
Prof.
University of Chile