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临床试验/NCT05850065
NCT05850065招募中不适用

Assessment of Gingival Health Following Different Retraction Techniques in Restorative Rubber-Dam Isolation

Marmara University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2023年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Relative Gingival Margin Level

研究概览

简要总结

The aim of this study is to evaluate the effect of retraction techniques on gingival health. Four different method (212 clamp (Hu-Friedy, USA); Brinker B4 clamp (Coltene Hygenic, USA); dental floss using the simple knot tie method; and using the simple knot tie and 212 clamp together) will evaluated. After rubber dam isolation restorations will be performed, each restoration will take maximum 30 minutes.

Changes in periodontal tissues will be evaluate; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level, relative attachment level and VAS (visual analogue scale) scoring and patient comfort levels after the procedure at different times (pre-restoration, after restoration, 1 week, 1 month, 3 month). The evaluation time is planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.

详细描述

In the present study study, it is aimed to perform gingival retraction under rubber-dam isolation by using a 212 clamp (Hu-Friedy, USA), a Brinker B4 clamp (Coltene Hygenic, USA), dental floss using the simple knot tie method, and using the simple knot tie and 212 clamp together. The study was planned as a split mouth. All of these methods will be applied systematically on upper incisors of each patient (teeth numbered 11-12-21-22) by changing them in a clockwise direction. The application time of the retraction methods in each tooth will be limited to 30 minutes, the working time is planned as 2 hours for a total of 4 teeth.

Before starting the treatment, patients will have to sign information and consent forms. In the present study, direct composite restorations are planned under local anesthesia, and it is planned to evaluate the effects of different retraction methods on periodontal tissues and patient comfort. After the retraction technique to be used, direct composite restorations will be performed. Restorations involving the cervical region veneer restorations; It will include aesthetic restorations in the maxillary anterior region, including cervical area. The preparation will only be made when necessary and will protect the hard tissues of the teeth as much as possible in minimally invasive way.

All restorations to be made in our study are planned to be applied with the 'additive' finishing technique. In this technique, the resin material is placed on the tooth surface in small pieces during composite layering and no 'overcontouring' is made. In this way, it is not necessary to reduce the areas close to the gingiva with a drill during the finishing of the restorations, especially concerning the cervical region, and periodontal tissues can be protected. In our study, it is aimed to eliminate the use of burs in the cervical area, which is an important parameter of possible damage to periodontal tissues, and to observe the effects of retraction methods by using this technique.

  • Data collection method Changes in periodontal tissues will be evaluate; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level, relative attachment level and VAS (visual analogue scale) scoring and patient comfort levels after the procedure at different times (pre-restoration, after restoration). It will be evaluated immediately after, 1 week later, 1 month later, 3 months later. The evaluation time is planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department. Periodontal evaluations will be performed as a single blind, the observer will not know which retraction method is applied to which teeth during the evaluation. Intra-observer agreement will be evaluated, and work will continue in the presence of agreement above 80%.

Restorative materials to be used in the study; Estelite Asteria (Tokuyama, Japan) with nano-hybrid properties will be used as resin composite for the restorations. A 37.5% phosphoric acid (Gel Etchant, Kerr Dental, USA) and a universal agent Tokuyama Universal Bond II (Tokuyama) will be used. For polymerization, Valo Cordless (Ultradent Products, USA) will be used in standard mode (/1000 mw/cm2). In case of, preparation is required, the type of atraumatic burs to be used as much as possible, red or yellow banded diamond burs (Acurata, Japan) and multi-blade tungsten carbide burs (Acurata) will be preferred.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-35
  • Have sufficient cognitive ability to understand the consent procedure
  • Clinically healthy gingiva and periodontium
  • Daily cigarette consumption of 10 or less
  • No attachment loss, bleeding on probing, or plaque buildup
  • Vital upper teeth (12-22) without signs of irreversible pulpitis
  • Patients with cervical lesions, abrasion lesions and/or indications for diastema closure requiring restoration
  • Patients with cervical lesions at or below the gingival level
  • Patients with direct composite restoration indications concerning the cervical region in their upper anterior 4 incisors.

排除标准

  • Any disability (mental health conditions, mentally handicapped and physically handicapped)
  • Systemic diseases or serious medical risks (Cardiovascular disorder, diabetes, hypertensive, epileptic)
  • Compliance problem, inability to provide post-treatment hygiene
  • Gingival hyperplasia or bleeding disorder
  • Signs of attachment loss of periodontal disease
  • Patients for whom rubber dam placement is contraindicated (patient with asthma diagnosis, mouth breathing, partially erupted tooth, overly malpositioned teeth and latex allergy).
  • Signs of periapical pathology or pulpal posterior or anterior pathology
  • Non-vital, endodontically treated teeth
  • Teeth which have mobility
  • Teeth with extraction indication

结局指标

主要结局

Relative Gingival Margin Level

时间窗: 3 months later

Relative Gingival Margin Level will measure for the evaluate to effect of different retraction methods on gingival tissue

Relative Attachment Level

时间窗: 3 months later

Relative Attachment Level will measure for the evaluate to effect of different retraction methods on gingival tissue

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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