跳至主要内容
临床试验/NCT05185206
NCT05185206Unknown不适用

Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study

Dr. D. Y. Patil Dental College & Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.

研究概览

简要总结

Cention-N(commercially available restorative material) is a cost effective restoration for posterior restorations. Post-operative sensitivity is of great concern as far as any type of restorative material is concerned. Reduction of post-operative sensitivity is still a major on-going research. Timely advancement has lead to the discovery and usage of polymer bur for reduction of excess tooth removal, and thus reduction of sensitivity. Therefore the novelty of this study is comparision of the post operative sensitivity of Cention-N(commercially available restorative material) using conventional and polymer bur using Visual Analog Scale.

详细描述

Dental caries is a multifactorial disease which is very much prevalent in India occurring especially in high economic group and some in middle and lower economic groups of world population.The most common instruments used for excavation of dental caries are the use of diamond and carbide burs.There is effective removal of the carious tooth structure through these burs which leads to excess removal of tooth structure and weakening the teeth.

Timely advancement in dentistry and the quest for the development of ideal esthetic materials to replace lost dental tissue has led to use of Cention-N(commercially available restorative material) to restore posterior teeth. Cention N(commerically available restorative material) is a recently introduced tooth-coloured, basic filling material for bulk placement in retentive preparations with or without the application of an adhesive. It is an alkise restorative which is a new category of filling material, like compomer(commercially available restorative material) or ormocer(commercially available restorative material) and is essentially a subgroup of the composite resin. Cention-N(commercially available restorative material)offers a cost-effective substitute for amalgam and also fulfills the need of an esthetic bulk fill material in the posterior region. Patients have described post-operative sensitivity as a moderate pain, of short duration, that appears spontaneously when chewing, with hot and cold foods and on rare occasions with sweet and acid foods, and it disappears when the stimulus is removed. It is characterized by an acute pain that can last for days or weeks and disappears when the stimulus is removed.It results from the interaction between the restorative technique, the clinical condition of the tooth to be treated (health of the pulp and remaining hard dental tissue) and the restorative material. Therefore, there is a permanent and unpredictable possibility of sensitivity occurring. In addition, there are other factors related to the cause of post- operative sensitivity, such as the individual profile of each patient, the shape and extension of the cavity preparation and protection of the dentin-pulp complex. Hence the novelty of this study is to evaluate of the post operative sensitivity of Cention-n (commerically available restorative material)using conventional and polymer bur.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The participants, investigator and outcome assessor will be blinded to the treatment modalities.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
  • •Roots with closed apex.
  • •Systematically healthy patients.
  • •Patients with no other symptomatic tooth involved

排除标准

  • •Teeth with the presence of any pathologic pulpal disease with or without pain.
  • •Teeth with previous restorations, any defective restoration adjacent to or opposing the affected tooth.
  • •Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
  • •Patients with poor oral hygiene, severe, or chronic periodontitis.
  • •Patient on medication which may hinder the response to sensitivity.

研究组 & 干预措施

Analysis of post-operative sensitivity after caries removal using conventional steel bur

Active Comparator

Caries will be excavated using a carbide on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.

干预措施: Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material). (Device)

Analysis of post-operative sensitivity after caries removal using polymer bur

Experimental

Caries will be excavated using a polymer on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.

干预措施: Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material). (Device)

结局指标

主要结局

Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.

时间窗: Post operative sensitivity will be checked after 30 days.

Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.

Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.

时间窗: Post operative sensitivity will be checked after 24 hours.

Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).

Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.

时间窗: Post operative sensitivity will be checked after 15 days.

Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).

次要结局

未报告次要终点

研究者

发起方
Dr. D. Y. Patil Dental College & Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soumya Shetty

Professor

Dr. D. Y. Patil Dental College & Hospital

研究点 (1)

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