Clinical evaluation of GrandioSO Heavy Flow in combination with the restorative material GrandioSO for Class I and II restorations

Not Applicable

• Conditions: K02.9; Dental caries, unspecified

• Registration Number: DRKS00033585
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg, Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie

Brief Summary

After 3 years cumulative survival rate including all restorations was 95.7%. Statistical analysis revealed significant differences for the parameter: tooth vitality, marginal discoloration, success rate, and AFR. The other parameters exhibited no significant differences. Consequently, the nanohybrid composite demonstrated excellent performance over a 3-year period, whereas the uti-lization of a flowable composite for cavity lining did not appear to exert a beneficial influence on clinical outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-03-27
• Study Start: 2024-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

signed consent form available
positive vitality
teeth needing indirect pulp capping
2 molars/premolars with Class I/II cavity lesions with:
- antagonist
- approximal contact
- bucco-oral extension at least one third of the spacing of tooth cusps

Exclusion Criteria

severe systemic diseases
allergies related to materials
pregnancy or breastfeeding
inadequate oral hygiene
preoperative pulpal symptoms
teeth needing direct pulp capping
endodontically treated teeth

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
48 months

Secondary Outcome Measures

Name	Time	Method
36 months