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

NCT04678141 | Completed DMC

• 1 other identifier: 72867572.050.01.04-207321
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Teeth

Keywords

class II; compomer; composite resin; primary molars; restoration

Outcome Measures

Primary Outcomes (1)

• USPHS criteria

  Clinical evaluation of composite resin and compomer restorations in primary molars

  up to 2 years

Study Arms (1)

Composite and compomer materials

OTHER

Children aged 5-6 years with at least two carious proximal surface primary molars

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)

Interventions

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) OTHER

compomer (Dyract XP,R\&D Series NOVA) , composite (Kerr Herculite Classic),Bonding (Clearfil TM SE Bond), Dycall (Hydrocal LC)

Composite and compomer materials

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \* Mentally and physically healthy

You may not qualify if:

• \* Systemic disease or medical complications

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Isparta, 32260, Turkey (Türkiye)

Location

Related Publications (4)

• Tseveenjav B, Furuholm J, Mulic A, Valen H, Maisala T, Turunen S, Varsio S, Auero M, Tjaderhane 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. Epub 2017 Dec 3.

  PMID: 29205613 RESULT

• 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.

  PMID: 29322626 RESULT

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

  PMID: 25905653 RESULT

• 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.

  PMID: 11132507 RESULT

Study Officials

• Esra Oz, Assist Prof

  Suleyman Demirel University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 21, 2020
• Study Start: July 23, 2018
• Primary Completion: October 23, 2018
• Study Completion: August 23, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)