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N/A N=93 Randomized Double-blind Treatment

High-strength Glass-ionomer Dental Restorations

Dental Caries

Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Survival Rate — 39; 44; 5; 2 Restorations — p=0.262

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Chemfil ROCK Glassionomer restoration (Device); Fuji IX GP Extra Glassionomer restoration (Device)
Age
Pediatric · 7+ yrs
Sex
All
Sponsor
Mathilde Peters, DMD, PhD
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Survival Rate
39; 44; 5; 2; 0; 0 0.262
SECONDARY
Caries Incidence Associated With Restoration
40; 39; 4; 7 0.523
SECONDARY
Restored Tooth Performance
44; 45; 0; 1 0.100

Summary

The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials. The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.

Eligibility Criteria

Inclusion Criteria

  • 7-16 year old
  • in need of one or two approximal fillings in molars

Exclusion Criteria

  • known allergies to calcium-aluminum-zinc-fluoro-phosphor-silicate glass or any other of glassionomer components
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01523613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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