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临床试验/NCT03917108
NCT03917108Unknown不适用

Assessment of Technique Sensitivity and Gingival Health in Management of Cervical Lesions Performed Using Subgingival Clamp Versus Retraction Cord: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 22 人开始时间: 2019年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
主要终点
Degree of patient satisfaction

研究概览

简要总结

assessing subgingival clamp in handling and retracting the gingival tissue at the cervical area to see its effect on the gingival health and its technique sensitivity compared to the most commonly used method (retraction cord), as gingival displacement for cervical restorations affects smile and therefore patient satisfaction with the result.

详细描述

Gingival displacement for restoring cervical lesions using retraction cord or subgingival clamp with their technique sensitivity affects the smile as they may cause gingival bleeding, laceration or recession and therefore affects patient satisfaction. There are several methods to achieve retraction; retraction cord is the most commonly used method. It controls the soft tissue displacement, gingival bleeding and expose the margins which provide good visualization and access.

They are effective and safe if the gingiva is healthy, also inexpensive retraction method. However, the use of retraction cord has some disadvantages like: it is time consuming, may cause gingival recession after healing and bleeding after removal, its application needs practice and skill as improper handling of the cord can cause traumatic injuries, gingival recession and marginal exposure of the restoration, it may cause postoperative discomfort and pain for the patient and finally leaving the retraction cord for long time or forgetting to remove it from the sulcus can cause permanent damage to the gingival tissue.

Using gingival retracting clamps with rubber dam isolation prevent the gap caused around the teeth due to vertical and horizontal tissue displacement occurred beneath the area of dento-gingival attachment upon the application of the retraction cord. Also, after clamp stabilization in position, it prevents accidental slippage and trauma to surrounding soft tissue during the restorative procedure. They also provide maximum tissue retraction without laceration of gingival tissues. Also, their availability in different sizes and shapes provide a good adaptation to any tooth configuration and any inaccessible area.

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
Single (Outcomes Assessor)

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

  • Subject not less than 18 years of age.
  • Males or females.
  • Have at least one carious or non-carious cervical lesion.
  • Cervical lesions should be equi-gingival or subgingival.
  • Can comply to oral hygiene measures or with good oral hygiene.
  • Have sufficient cognitive ability to understand consent procedures.
  • Vital upper or lower teeth with no signs or symptoms of irreversible pulpitis.
  • Clinically healthy gingiva and periodontium.
  • No evidence of attachment loss, bleeding on probing, or plaque accumulation.
  • Exclusion criteria:

排除标准

  • Patients less than 18 years old.
  • Disabilities (mental health conditions, intellectual disability and physical disabilities).
  • Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic.
  • Lack of compliance.
  • Gingival hyperplasia, blood disorder.
  • Attachment loss signs of periodontal disease.
  • Patients contra-indicated for rubber dam placement (Asthmatic patient, mouth breather, -- partially erupted tooth, extremely malposed teeth and latex allergy).
  • Periapical pathosis or signs of pulpal posterior or anterior pathology.
  • Non-vital tooth.
  • Endodontically treated tooth.
  • Sever periodontal affection.
  • Tooth indicated for extraction.

研究组 & 干预措施

retraction cord

Active Comparator

干预措施: retraction cord (Device)

subgingival clamp

Other

干预措施: subgingival clamp (Device)

结局指标

主要结局

Degree of patient satisfaction

时间窗: Immediately after application

Using visual analogue scale (units on scale from 0-10)

Time of application

时间窗: Immediately after application

Assessed using timer and the measuring unite is seconds

Number of patients need local anesthesia

时间窗: Immediately after application

It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question

Degree of isolation from cervical fluids

时间窗: Immediately after application

Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result

次要结局

  • Amount of gingival bleeding(4 month)
  • Pink esthetics evaluation(4 month)
  • Degree of gingival sensitivity(4 month)
  • Presence of gingival laceration(4 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Hamada Ahmed Shehab Eldin

principal investigator in Cairo university

Cairo University

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