Clinical trial NCT04678141: Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results
Official title: Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Teeth
Keywords: class II
compomer
composite resin
primary molars
restoration
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 145
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

\* Mentally and physically healthy

Exclusion Criteria:

\* Systemic disease or medical complications

Primary outcomes:
measure: USPHS criteria
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Study officials:
affiliation: Suleyman Demirel University
name: Esra Oz, Assist Prof
role: STUDY_DIRECTOR
References:
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citation: Chisini LA, Collares K, Cademartori MG, de Oliveira LJC, Conde MCM, Demarco FF, Correa 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 2018 Jan 10.
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.
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.