Clinical Trials Directory

Trials / Completed

CompletedNCT04678141

Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
145 (actual)
Sponsor
Suleyman Demirel University · Academic / Other
Sex
All
Age
5 Years – 6 Years
Healthy volunteers
Accepted

Summary

It was aimed to evaluate the clinical performance of resin-hybrid composite and compomer materials in primary molars over a 2-year period.

Detailed description

All treatment stages were performed by the same experienced pediatric dentist (E.O.) to avoid behavioral problems. When necessary, topical anesthesia with 2% Xylocaine® DENTAL was administered, followed by local anesthesia with epinephrine 1: 100.000 (lidocaine HCl and Epinephrine Injection, DENTSPLY Pharmaceutical, USA). Access to proximal surfaces was provided with high-speed diamond bur (FD.D.801, Frank Dental, Germany) under an air-water coolant. The proximal cavity was opened at the occlusal level. Soft carious dentine was removed with a round low-speed steel bur (SS.1A, Frank Dental, Germany). Restorations were placed under isolation with cotton rolls and a saliva ejector. The Ca(OH)2 cavity liner material (Hydrocal LC, Medicept Dental, India) was used as base material if the distance from the pulp was not safe. A metal matrix band (Matrix band, Hahnenkratt, Königsbach-Stein, Germany) was applied to the tooth with a universal matrix system (Tofflemire, Hahnenkratt, Königsbach-Stein, Germany) and wooden wedges (TDV, No 1). ClearfilTM SE Bond (Kuraray Medical Inc, Okayama, Japan) was applied to the cavity according to the manufacturer's instructions. For the polymerization, an LED curing light (Eliapar Freelight, 3M ESPE Dental Products, America) was used with a light power density of 600 mW/cm2. According to the manufacturer's instructions, A2 composite resin (Kerr Herculite Classic) and two different compomer materials (Dyract/XP and R\&D Series NOVA) were applied to the teeth with the incremental technique, and each increment was light-polymerized for 20 sec with an LED curing light.

Conditions

Interventions

TypeNameDescription
OTHERDyract XP (Dentsply De Trey), Kerr Herculite Classic (Kerr Corporation),R&D Series NOVA(Kuraray Medical Inc) Clearfil TM SE Bond (Kuraray Medical),Hydrocal LC (Medicept Dental)compomer (Dyract XP,R\&D Series NOVA) , composite (Kerr Herculite Classic),Bonding (Clearfil TM SE Bond), Dycall (Hydrocal LC)

Timeline

Start date
2018-07-23
Primary completion
2018-10-23
Completion
2020-08-23
First posted
2020-12-21
Last updated
2022-07-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04678141. Inclusion in this directory is not an endorsement.