NCT06235489

Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars

"Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.

Detailed description

1. Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS). 2. Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study. 3. Each patient will be assigned to one of the two groups. * Group I (n= 59): Plafique Bulk Flow Composite. * Group II (n=59): EQUIA Forte Group. 4. Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities. 5. Matrix is placed and secured in position. 6. One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions. 7. Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria. 8. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption. 9. They will be given manual tooth brushes and tooth pastes to use during the study.

Conditions

• Dental Caries Class II

Interventions

Type	Name	Description
OTHER	Palfique Bulk Flow	removal of caries in primary molars and placement of restorative materials

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: Egypt