High-strength Glass-ionomer Dental Restorations (ROCK)

Mathilde Peters, DMD, PhD

Status: Completed

Conditions: Dental Caries

Treatments: Device: Fuji IX GP Extra Glassionomer restoration; Device: Chemfil ROCK Glassionomer restoration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01523613

N013822

11-PAF05343 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 3 patient groups

ROCK - Single Restorations

Active Comparator group

Description:

ChemFil Rock glassionomer restoration

Treatment:

Device: Chemfil ROCK Glassionomer restoration

Fuji IX GP - Single Restorations

Active Comparator group

Description:

Fuji IX GP Extra glassionomer restoration

Treatment:

Device: Fuji IX GP Extra Glassionomer restoration

Rock AND Fuji - Paired Restorations

Active Comparator group

Description:

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.

Treatment:

Device: Chemfil ROCK Glassionomer restoration

Device: Fuji IX GP Extra Glassionomer restoration