High-strength Glass-ionomer Dental Restorations

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Chemfil ROCK Glassionomer restoration; Device: Fuji IX GP Extra Glassionomer restoration

• Registration Number: NCT01523613
• Lead Sponsor: Mathilde Peters, DMD, PhD

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Results First Submitted: 2017-07-15
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-05
• Last Update Submitted: 2017-09-05
• Results First Posted: 2017-10-03
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROCK - Single Restorations	Chemfil ROCK Glassionomer restoration	ChemFil Rock glassionomer restoration
Fuji IX GP - Single Restorations	Fuji IX GP Extra Glassionomer restoration	Fuji IX GP Extra glassionomer restoration
Rock AND Fuji - Paired Restorations	Chemfil ROCK Glassionomer restoration	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.
Rock AND Fuji - Paired Restorations	Fuji IX GP Extra Glassionomer restoration	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.

Primary Outcome Measures

Name	Time	Method
Survival Rate	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 Outcome Measures

Name	Time	Method
Caries Incidence Associated With Restoration	2 years	- "Caries free restorations" is defined as: free of caries associated with restoration.
Restored Tooth Performance	2 years	* Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms.; * "Clinically successful" is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality.

Trial Locations

Locations (1)

Mott Childrens' Health Center; 🇺🇸 Flint, Michigan, United States