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

Primary Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678141
• Other study ID #: 72867572.050.01.04-207321
• Status: Completed
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: August 23, 2020

Study information

• Verified date: July 2022
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 23, 2020
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

Inclusion Criteria:

• Mentally and physically healthy

Exclusion Criteria:

• Systemic disease or medical complications

Related Conditions & MeSH terms

• Primary Teeth

Intervention

Other:
• Dyract 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)

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Chisini LA, Collares K, Cademartori MG, de Oliveira LJC, Conde MCM, Demarco FF, Corrêa MB. Restorations in primary teeth: a systematic review on survival and reasons for failures. Int J Paediatr Dent. 2018 Mar;28(2):123-139. doi: 10.1111/ipd.12346. Epub 2 — View Citation

Fuks AB, Araujo FB, Osorio LB, Hadani PE, Pinto AS. Clinical and radiographic assessment of Class II esthetic restorations in primary molars. Pediatr Dent. 2000 Nov-Dec;22(6):479-85. — View Citation

Fuks AB. The use of amalgam in pediatric dentistry: new insights and reappraising the tradition. Pediatr Dent. 2015 Mar-Apr;37(2):125-32. Review. — View Citation

Tseveenjav B, Furuholm J, Mulic A, Valen H, Maisala T, Turunen S, Varsio S, Auero M, Tjäderhane L. Survival of extensive restorations in primary molars: 15-year practice-based study. Int J Paediatr Dent. 2018 Mar;28(2):249-256. doi: 10.1111/ipd.12348. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	USPHS criteria	Clinical evaluation of composite resin and compomer restorations in primary molars	up to 2 years