Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Locations
- 2
- Primary Endpoint
- Survival Rate
Study Overview
Brief 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.
Detailed Description
In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Although material allocation was masked to evaluators, at times a difference in appearance (translucency) of the restorations at recall may have given it away.
Eligibility Criteria
- Ages
- 7 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ROCK - Single Restorations
ChemFil Rock glassionomer restoration
Intervention: Chemfil ROCK Glassionomer restoration (Device)
Fuji IX GP - Single Restorations
Fuji IX GP Extra glassionomer restoration
Intervention: Fuji IX GP Extra Glassionomer restoration (Device)
Rock AND Fuji - Paired Restorations
ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.
While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration.
Intervention: Chemfil ROCK Glassionomer restoration (Device)
Rock AND Fuji - Paired Restorations
ChemFil Rock glassionomer restoration AND Fuji IX GP Extra glassionomer restoration.
While this is not truly a separate arm for outcome analysis, this "arm" represents those individuals who had paired restorations, one of each: 1 ChemFil Rock restoration and 1 Fuji IX GP restoration.
Intervention: Fuji IX GP Extra Glassionomer restoration (Device)
Outcomes
Primary Outcomes
Survival Rate
Time Frame: 2 years
* Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms. * "Clinically successful" is defined as: no need for replacement due to fracture or retention losses.
Secondary Outcomes
- Caries Incidence Associated With Restoration(2 years)
- Restored Tooth Performance(2 years)
Investigators
Mathilde Peters, DMD, PhD
Professor
University of Michigan