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High-strength Glass-ionomer Dental Restorations (ROCK)

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chemfil ROCK Glassionomer restoration
Fuji IX GP Extra Glassionomer restoration
Sponsored by
Mathilde Peters, DMD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Glass-ionomer

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Mott Childrens' Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

ROCK - Single Restorations

Fuji IX GP - Single Restorations

Rock AND Fuji - Paired Restorations

Arm Description

ChemFil Rock glassionomer restoration

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.

Outcomes

Primary Outcome Measures

Survival Rate
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

Caries Incidence Associated With Restoration
- "Caries free restorations" is defined as: free of caries associated with restoration.
Restored Tooth Performance
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.

Full Information

First Posted
January 27, 2012
Last Updated
September 5, 2017
Sponsor
Mathilde Peters, DMD, PhD
Collaborators
Mott Children's Health Center, Dentsply International
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1. Study Identification

Unique Protocol Identification Number
NCT01523613
Brief Title
High-strength Glass-ionomer Dental Restorations
Acronym
ROCK
Official Title
Clinical Performance of High-Viscous Glass-Ionomer Restorative Systems In Class II Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mathilde Peters, DMD, PhD
Collaborators
Mott Children's Health Center, Dentsply International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Glass-ionomer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ROCK - Single Restorations
Arm Type
Active Comparator
Arm Description
ChemFil Rock glassionomer restoration
Arm Title
Fuji IX GP - Single Restorations
Arm Type
Active Comparator
Arm Description
Fuji IX GP Extra glassionomer restoration
Arm Title
Rock AND Fuji - Paired Restorations
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Chemfil ROCK Glassionomer restoration
Other Intervention Name(s)
HVGIC, HV-GIC, ART materials
Intervention Description
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
Intervention Type
Device
Intervention Name(s)
Fuji IX GP Extra Glassionomer restoration
Other Intervention Name(s)
Fuji Equia, HVGIC, HV-GIC, ART materials
Intervention Description
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Primary Outcome Measure Information:
Title
Survival Rate
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Caries Incidence Associated With Restoration
Description
- "Caries free restorations" is defined as: free of caries associated with restoration.
Time Frame
2 years
Title
Restored Tooth Performance
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde C Peters, DMD, PhD
Organizational Affiliation
U Michigan
Official's Role
Study Director
Facility Information:
Facility Name
Mott Childrens' Health Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

High-strength Glass-ionomer Dental Restorations

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