NCT07243496

Composite Restoration of Class II Cavities in Primary Molars With or Without Pulpotomy. Prospective 24 Month Clinical Trial.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Lygidakis Dental Clinic · Academic / Other
• Sex: All
• Age: 3 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

After 24 months: * Investigation of the success rate of Class II composite resin restorations in primary molars that have undergone pulpotomy. * Comparison of Class II composite resin restorations in primary molars that have undergone pulpotomy with restorations of the same type in the same patient, in which no pulpotomy has been performed. The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.

Conditions

• Composite Restoration
• Primary Tooth Pulpotomy

Interventions

Type	Name	Description
PROCEDURE	Class II restoration after pulpotomy	The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. After pulpotomy completion with a layer of MTA®, an intermediate layer of glass ionomer cement (Vitrebond Plus™) is placed before the final composite resin restoration. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™).
PROCEDURE	Class II restoration without pulpotomy	The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™).

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: Greece