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临床试验/CTRI/2024/11/076881
CTRI/2024/11/076881招募中不适用

Comparative evaluation of clinical performance of One shade Universal Composite and Universal Nanohybrid Composite in non carious cervical lesions and after artificial ageing - A two year randomised clinical study

Dr Pradnya V Bansode1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Comparative evaluation of One Shade Universal Composite resin and Universal Nanohybrid composite resin using digital VITA Shade Guide & modified USPHS criterion to evaluate -

研究概览

简要总结

This study involves Invivo and Invitro comparative evaluation of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin. 80 patients of age group 18 years - 35 years having non carious cervical lesions in atleast two maxillary premolars will be selected for the study after obtaining their informed consent in writing. After preparation of standardised class V cavities at the cervical lesions the two composite resins will be used to restore the same using standardised protocol and as per manufacturers instructions. Clinical evaluation One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin will be done using Digital VITA Shade Guide and using the USPHS Criteria to evaluate marginal discolouration, marginal integrity, surface texture, wear, post operative sensitivity and recurrent caries. The findings will be recorded at baseline, 6 months, 12 months, 18 months and 24 months. There will be blinding of the evaluators who will be evaluating the restorations at the said intervals.

The Invitro part of the study involves preparation of 80 discs each of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin having 8 mm diameter and 2 mm depth. All the discs will be subjected to artificial ageing by following the thermocycling protocol for 2 years. Evaluation for shade, surface roughness and microhardness will be done at baseline, 12 months and 24 months. The values will be recorded and saved for statistical analysis.

This study is unique as there will be long term clinical evaluation between One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin and also invitro laboratory comparative evaluation of the disc specimens of the said materials will be carried out.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • patients with atleast two non carious small and shallow cervical abrasions in maxillary premolars.
  • Good Oral Hygiene.
  • Patients willing to participate in the study and co-operate during the study tenure.

排除标准

  • (a) Poor oral hygiene (b) Severe or active periodontal disease.
  • (c) Caries and lack of compliance.
  • (d) Non vital teeth (e) Fractured or visibly cracked teeth (1) Patient will be excluded if the patient withdraws or opts out of study before 12 months.

结局指标

主要结局

Comparative evaluation of One Shade Universal Composite resin and Universal Nanohybrid composite resin using digital VITA Shade Guide & modified USPHS criterion to evaluate -

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

1) marginal discoloration

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

2) marginal integrity

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

3) surface texture

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

4) wear

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

5) postoperative sensitivity

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

6) recurrent caries

时间窗: Baseline, 6 months, 12 months, 18 months, 24 months

次要结局

  • Invitro Comparative evaluation of One Shade Universal Composite Resin and Universal Nanohybrid Composite Resin after preparation of 80 resin discs each of both the materials. Shade, surface roughness and microhardness will be evaluated and compared(Thermocycling of composite resin discs will be done to create artificial ageing. Values will be recorded at baseline, 12 months and 24 months.)

研究者

发起方
Dr Pradnya V Bansode
申办方类型
Other [Self financed]
责任方
Principal Investigator
主要研究者

Pradnya V Bansode Wadikar

Govt Dental College And Hospital Chhatrapati Sambhajinagar

研究点 (1)

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