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临床试验/CTRI/2021/03/031937
CTRI/2021/03/031937尚未招募不适用

Comparative evaluation of clinical success of Pre-veneered Stainless steel crowns, Cellulose crowns and two types of Zirconia Crowns in primary anterior teeth – A Prospective randomized follow up clinical study.

self funded1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1)To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria:

研究概览

简要总结

Study Design: Prospective Randomized clinical study.

Study setting: This is an in-vivo study that will be conducted to evaluate and compare clinical success of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns.

Study Population: The patients visiting the Department of Pediatric and Preventive Dentistry in a college of Western Maharashtra.

Sample Size: The study will be carried out on 32 teeth requiring full coverage restoration.

Appropriate Sampling technique: Selection of teeth will be done by lottery method. All the sample will be distributed into four groups.

Study Place: Western Maharashtra.

Study Period: 12 months.

Method of selection of study subjects:

Inclusion Criteria:

Parents willing to give consent.

Vital Primary teeth indicated for full coverage restoration.

Frankel’s positive and definitely positive patients

Children aged between 3 to 6 years.

No significant medical history.

Adequate root support should be present.

Exclusion Criteria:

Non-vital primary anterior teeth.

Traumatized primary anterior teeth.

Children with special needs

Inadequate root length.

Appropriate study instruments:

Mouth mirror

Probe

Cotton rolls and gauzes

Local anaesthesia with adrenaline(1:2,00,000)

Kids E Crown (ODS Cad Cam centre, parel, Mumbai.)

Nu-Smile crown (TEXAS, USA)

ES White crown (SEATTLE, WA)

Strip crown (3M ESPE,2510 Convay Avenue, USA)

Resin- modified cement

Burs and Hand piece

Methods of Data collection:

After obtaining ethical clearance from institutional ethics committee, the baseline data will be collected on the basis of inclusion criteria. The 32 samples will be randomly divided into four groups,8 teeth each as follows:

Group A: primary teeth with kids-e-crowns. (ODS Cad Cam centre, parel, Mumbai.)

Group B: primary teeth with Nu-smile crowns. (TEXAS, USA)

Group C: primary teeth with ES White crowns. (SEATTLE, WA)

Group D: primary teeth with Strip crowns (3M ESPE,2510 Convay Avenue,USA)

Group A, Group B ,Group C and Group D

A complete case history of the patient will be recorded.

Radiographs and Photographs will be taken.

Oral prophylaxis will be performed.

Teeth requiring full coverage restoration will be selected and isolated.

A stopwatch will be used to measure time taken for the procedure.

After anaesthesia execution, the crown size selection will be done.

According to the manufacturing instructions, tooth preparation will be done and occlusion will be assessed. Prepared tooth should be free from the blood, saliva, residues prior to crown cementation.

Resin cement will be employed for luting.

After cementation, the crown surface is cleaned and flossing will be done in the interdental area to remove excess cement.

Post-operative radiographs will be recorded.

The samples will be assessed as follows:

1.      Crown assessment:

Clinical

Radiographical

2.      Patient and parent satisfaction according to USPHS criteria.

3.      Occlusion

4.      The color match will be checked by Casmatch system on each recall

The patient will be recalled after 1 month, 3 month, 6 month, 9 month and 12 month.

研究设计

研究类型
Interventional

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Parents willing to give consent.
  • Vital Primary teeth indicated for full coverage restoration.
  • Frankel’s positive and definitely positive patients 4)Children aged between 3 to 6 years.
  • No significant medical history.
  • Adequate root support should be present.

排除标准

  • Non-vital primary anterior teeth.
  • Traumatized primary anterior teeth.
  • Children with special needs.
  • Inadequate root length.

结局指标

主要结局

1)To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria:

时间窗: 1.To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria: | 2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns). | 3)Colour match (with natural teeth using Casmatch). | 4)Colour stability (Over a period of time, change in colour of crown due to plaque retention). | 5)Occlusion (bilateral harmony after placement of crown).

2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns).

时间窗: 1.To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria: | 2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns). | 3)Colour match (with natural teeth using Casmatch). | 4)Colour stability (Over a period of time, change in colour of crown due to plaque retention). | 5)Occlusion (bilateral harmony after placement of crown).

3)Colour match (with natural teeth using Casmatch).

时间窗: 1.To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria: | 2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns). | 3)Colour match (with natural teeth using Casmatch). | 4)Colour stability (Over a period of time, change in colour of crown due to plaque retention). | 5)Occlusion (bilateral harmony after placement of crown).

4)Colour stability (Over a period of time, change in colour of crown due to plaque retention).

时间窗: 1.To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria: | 2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns). | 3)Colour match (with natural teeth using Casmatch). | 4)Colour stability (Over a period of time, change in colour of crown due to plaque retention). | 5)Occlusion (bilateral harmony after placement of crown).

5)Occlusion (bilateral harmony after placement of crown).

时间窗: 1.To compare clinical success of Pre-veneered, Cellulose crowns and two types of Zirconia Crowns under following criteria: | 2)Duration (Time required for placement of Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns). | 3)Colour match (with natural teeth using Casmatch). | 4)Colour stability (Over a period of time, change in colour of crown due to plaque retention). | 5)Occlusion (bilateral harmony after placement of crown).

次要结局

  • To compare, gingival health of a patient after using Pre-veneered Stainless Steel crowns, Cellulose crowns and two types of Zirconia Crowns.
  • To compare parent’s acceptance for Pre-veneered Stainless Steel Crowns, Cellulose crowns and two types of Zirconia Crowns.(nil)

研究者

发起方
self funded
申办方类型
Research institution

研究点 (1)

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