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临床试验/CTRI/2024/12/077894
CTRI/2024/12/077894尚未招募3 期

Comparative Evaluation of Clinical Success with Preformed Stainless Steel Crowns and Bioflex Crowns 9 Month Follow up Study

Nikhitha Elsa Shaji1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
1.Crown retention will be evaluated as intact/displaced, chipped/broken/fracture, complete loss of crown.

研究概览

简要总结

Dental caries is a public health concern especially in children and young adolescents. Preformed metal crowns also known as Stainless steel crowns is a gold standard for posterior full coverage restorations. Due to technological advancement, a flexible, esthetically appealing crown- Bioflex crowns has been introduced. This randomized control trial is done to evaluate clinical success, clinician and patient satisfaction between two groups- Group A: Stainless steel crowns and Group B: Bioflex Crowns. This study will be conducted in 20 children who require pulpectomy procedure for the lower second primary molars, visiting the department of Pedodontics, Sri Siddhartha dental college, Tumkur. Crown preparation will be done according to the manufacturer’s instruction. the crown will be placed using the type 1 glass ionomer cement. There will be a follow up period of 1 week, 3 months, 6 months and 9 months to evaluate the clinical success between the two groups. Plaque retention will be evaluated using Sillness-Loe Plaque index and gingival index will be evaluated using  Loe-Sillness gingival index. Clinical success will be evaluating by assessing the marginal integrity, opposite tooth wear, crown retention, stain resistance and proximal contact area, during the follow up period. Pain and anxiety of the patient will be evaluated using the Animated emoji scale and Venham Picture test during the pre-op and post op periods and FLACC scale during the treatment. Clinician satisfaction will be evaluated by assessing the time taken during the placement of the crowns and by 5 point Likert scale assessing the surface gloss, roughness aesthetic and anatomical form after the treatment and during follow up.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children in the age group between 4 to 8 years indicated for pulpectomy
  • Cooperative children
  • Lower second primary molars after pulpectomy procedure.
  • Lower second primary molars having two thirds of root structure left radiographically.

排除标准

  • Uncooperative children (Frankl behavior: definitely negative)
  • Tooth mobility
  • A pathological root resorption
  • Primary molars not having sufficient crown structure •Primary molars with root caries.

结局指标

主要结局

1.Crown retention will be evaluated as intact/displaced, chipped/broken/fracture, complete loss of crown.

时间窗: 3, 6 and 9 months follow up

2.Stain resistance will be evaluated as no staining, minor staining and noticeable staining.

时间窗: 3, 6 and 9 months follow up

3. Opposing tooth will be evaluated as wear, no wear.

时间窗: 3, 6 and 9 months follow up

4. Marginal integrity will be determined through visible inspection and tactile examination with an explorer as closed margin and open margin.

时间窗: 3, 6 and 9 months follow up

5. Proximal contact area between the first and second molar will be recorded as intact or lost by passing a dental floss.

时间窗: 3, 6 and 9 months follow up

6. Clinician satisfaction criteria will be evaluated as surface gloss, roughness, aesthetic and anatomical form using five-point Likert’s scale.

时间窗: 3, 6 and 9 months follow up

7. Children’s acceptance to the treatment will be evaluated by the Smiley scale

时间窗: 3, 6 and 9 months follow up

次要结局

  • Gingival status(Periodontal status)

研究者

发起方
Nikhitha Elsa Shaji
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nikhitha Elsa Shaji

SRI SIDDHARTHA DENTAL COLLEGE, TUMKUR

研究点 (1)

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