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临床试验/NCT05340595
NCT05340595已完成不适用

Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer

Ondokuz Mayıs University0 个研究点目标入组 26 人开始时间: 2014年3月2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
26
主要终点
Bond Failure Rate of a Mandibular Bonded Lingual Retainer

研究概览

简要总结

Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.

Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.

The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P < 0.05.

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 (Participant)

入排标准

年龄范围
11 Years 至 34 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who will continue to the retention phase after fixed orthodontic treatment,
  • Presence of all mandibular incisor and canine teeth,
  • Good oral hygiene,
  • No fractures,
  • Healthy periodontal condition,
  • No restorations,
  • No previous bonded retainer,
  • No traumatic parafunctional habits such as bruxism.

排除标准

  • 未提供

研究组 & 干预措施

Control group

Other

The primer (Transbond XT Primer; 3M Unitek, California) was applied in a thin and uniform coat. Then the adhesive resin (Transbond LR Light Cure Adhesive Paste; 3M Unitek, California) was administered to the lingual surface of the anterior teeth and the lingual retainer was placed in position. The adhesive resin was polymerized from two directions for a total of 20 s using a visible-light curing unit (Hilux 200, Benlioglu Dental Inc., Ankara, Turkey) with an output power of 600 mW/cm2.

干预措施: Orthodontic retainer bonding (Other)

Study group

Active Comparator

In the study group, the SEP (3M Unitek, Monrovia, California) was used according to the manufacturer's instructions, namely it was administered to the lingual surfaces of the teeth and rubbed for 3 s. Then a gentle burst of dry air was delivered to thin the primer. In the control group, the lingual surfaces of the teeth were etched using 37% phosphoric etchant liquid gel (3M Espe, St Paul, Minnesota, USA) for 30 s, followed by rinsing and drying.

干预措施: Orthodontic retainer bonding (Other)

结局指标

主要结局

Bond Failure Rate of a Mandibular Bonded Lingual Retainer

时间窗: 24 months

Bond Failure Rate of a Mandibular Bonded Lingual Retainer

次要结局

未报告次要终点

研究者

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

Dr. Fethiye ÇAKMAK ÖZLÜ

Associate Professor

Ondokuz Mayıs University

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Effect of Primer Application on the Lingual Retainer | 临床试验