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 satisfaction

Evaluation Of The Clinical Performance Of Strip Crown Restorations With Composite Resin Vs Glass Hybrid Restorative System For Primary Anterior Teeth Of Children With Early Childhood Caries Ã¢â?¬â?? A Double Blind, Parallel Group, Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044918

Enrollment

Registered

2022-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Rashmi Nayak

Manipal College of Dental Sciences, Manipal Academy Of Higher Education, Manipal

rashmi.nayak@manipal.edu9845364987

Outcome results