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This is a clinical trial to evaluate performance of two filling materials (Composite Resin & Glass Hybrid Restorative System) as strip crown restoration for upper front milk teeth of children with Early Childhood Caries, in aspects of shape, shade, strength ,gum health & parental satisfactio

Phase 4
Registration Number
CTRI/2022/08/044918
Lead Sponsor
Dr Nidhi Malik
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Healthy 2.5-6 years old children with Early Childhood Caries requiring restoration of multi surface caries with at least one intact surface or class 4 lesions in maxillary primary incisors only. (2 teeth only)

2. Radiographically, the depth of caries in the tooth to be restored is restricted to outer two thirds of dentin with no signs of irreversible pulpitis.

3. Anterior Teeth with favorable occlusal clearance.

4. Expected life for tooth is at least 1.5 years.

Exclusion Criteria

1. Patients above the age of 6 years

2. Patients allergic to the material constituents being used for the study

4. Missing antagonist teeth

5. Teeth with physiological or pathological root resorption

6. Patients with parafunctional habits such as bruxism/nail biting/tongue thrusting

7. Physiological mobility

8. Patients with significant or long-term illness

9. Teeth fractured due to trauma / history of trauma

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The clinical performance of Glass Hybrid Restorative system as strip crowns with Composite Resin strip crowns in case of Early Childhood Caries using the FDI criteria.Timepoint: The clinical performance of Glass Hybrid Restorative system as strip crowns with Composite Resin strip crowns in case of Early Childhood Caries using the FDI criteria - 1,3,6 months
Secondary Outcome Measures
NameTimeMethod
Secondary outcome measure will be parental satisfaction with Glass Hybrid Restorative system as Primary Anterior Restoration using the 5 point Likert ScaleTimepoint: Secondary outcome measure will be parental satisfaction with Glass Hybrid Restorative system as Primary Anterior Restoration using the 5 point Likert Scale - 1, 3, 6 months
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