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临床试验/CTRI/2025/01/079473
CTRI/2025/01/079473招募中4 期

Assessment of clinical performance of resin modified Glass lonomer Cement, nanohyhrid and nanofillcd single shade composites in non-carious cervical lesions using a modified USPHS criteria - A Randomised Controlled Trial.

未提供1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月4日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
SINGLE SHADE COMPOSITES ARE MORE EFFICIENT THAN RESIN MODIFIED GIC

研究概览

简要总结

Patients with non-carious cervical lesions fulfilling the inclusion criteria will be selected. Total sample size will be equally divided into three groups i.e. RMGIC, Nanohybrid or Nanofilled Composite.

Clinical Procedure

After providing patient information sheet to the participant, written informed consent will be obtained.

The procedure will be conducted with the help of magnification (2.5X). All the participants will have to undergo oral prophylaxis 2 weeks before the placement of restoration.

Isolation

Isolation will be done with the help of rubber dam (Coltene Whaledent, USA).

Tooth preparation for restoration

The lesions will be cleaned with prophylaxis paste and rubber cup to remove the topped deposits at the time of restoration. The lesions will not be prepared with rotary instruments following the guidelines of the American Dental Association Acceptance program that do not allow placement of bevel (26)

Restorative Procedure For Resin Modified GIC

After isolation, the Universal adhesive system (Gluma Bond Universal) (14) will be applied with the aid of microbrush applicator for 20 seconds then light cured for 10 seconds with the help of light curing device. Then according to manufacturer’s instructions, the restorative material will be manipulated and the cavity will be restored then Light cured upto 3mm depth for 20 secs.

  Restorative Procedure for Nanohybrid Composite

The cavity will be dried with air and then Universal adhesive system (Gluma Bond Universal) will be applied with the aid of microbrush applicator for 20 seconds then light cured for 10 seconds with the help of light curing device. Then according to manufacturer’s instruction, the cavity will be restored then Light cured upto 3mm depth for 20 secs.

Restorative Procedure for Nanofilled Composite

Then cavity will be dried with air and then Universal adhesive system (Gluma Bond Universal) will be applied with the aid of microbrush applicator for 20 seconds then light cured for 10 seconds with the help of light curing device. Then according to manufacturer’s

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • A )Patient Related
  • Aged 18 to 65 will be included in the study (13)
  • Both male and female
  • Right handed patients
  • Good oral hygiene & Patients with healthy periodontal status (Oral Hygiene Index-Simplified) (23)
  • Low caries index (DMFT index of less than 12) B) Teeth Related
  • Mandibular 1st premolar with hypersensitivity evaluated by air blast test
  • Left side vital teeth.
  • evaluated by electric pulp testing
  • Supragingival wedge or saucer shaped lesions.

排除标准

  • Caries involving the cervical area
  • Restorations near the teeth to be restored
  • Crack teeth
  • Habits such as tobacco chewing, pan , alcohol, smoking etc
  • Advanced periodontitis
  • Patients undergoing orthodontic treatment or having prosthesis.

结局指标

主要结局

SINGLE SHADE COMPOSITES ARE MORE EFFICIENT THAN RESIN MODIFIED GIC

时间窗: 24hrs, 3 months, 6 months

次要结局

  • NANOHYBRID SINGLE SHADE COMPOSITE IS MORE EFFICIENT THAN NANOFILLED(6 MONTHS)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

URJA PIRAJI MALI

Department of Conservative Dentistry and Endodontics

研究点 (1)

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