Dental Caries
Conditions
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Dental restorations, Glass-ionomer
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.
Interventions
DEVICEChemfil ROCK Glassionomer restoration
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
DEVICEFuji IX GP Extra Glassionomer restoration
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Sponsors
Mott Children's Health Center
Dentsply International
Mathilde Peters, DMD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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
Sex/Gender
ALL
Age
7 Years to 16 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ChemFil Rock Restoration (R-single) Dental restoration made of ChemFil Rock, a high-viscous glassionomer restorative used as posterior dental filling material (no cavity conditioning, no coating of finished restoration) | 30 |
| Fuji IX Restoration (F-single) Dental restoration made of Fuji IX GP Extra, a high-viscous glassionomer restorative used as posterior dental filling material (using Cavity Conditioner and GC-Coat Plus). | 30 |
| Paired Restorations (1R and 1F) 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 restorative and 1 Fuji IX GP restorative. | 33 |
| Total | 93 |
Baseline characteristics
| Characteristic | ChemFil Rock Restoration (R-single) | Fuji IX Restoration (F-single) | Paired Restorations (1R and 1F) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 33 Participants | 93 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 26 Participants | 26 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 15 Participants | 22 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 15 Participants | 11 Participants | 34 Participants |
| Region of Enrollment United States | 30 Participants | 30 Participants | 33 Participants | 93 Participants |
| Sex: Female, Male Female | 20 Participants | 15 Participants | 21 Participants | 56 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 12 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
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.
Time frame: 2 years
Population: * 21 Subjects with 2 paired restorations (21 R, 21 F).~* 48 Subjects with a single restoration (23 R, 25 F).~* Recall total: 69 subjects, 90 restorations.~* No retention losses: all restorations (both R and F) in-situ and bonded; no exposed dentin.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ChemFil Rock Restoration (R) | Survival Rate | Clinically successful | 39 Restorations |
| ChemFil Rock Restoration (R) | Survival Rate | Replaced due to fracture | 5 Restorations |
| ChemFil Rock Restoration (R) | Survival Rate | Replaced due to loss of retention | 0 Restorations |
| Fuji IX Restoration (F) | Survival Rate | Clinically successful | 44 Restorations |
| Fuji IX Restoration (F) | Survival Rate | Replaced due to fracture | 2 Restorations |
| Fuji IX Restoration (F) | Survival Rate | Replaced due to loss of retention | 0 Restorations |
p-value: 0.262Fisher Exact
Secondary
Caries Incidence Associated With Restoration
\- Caries free restorations is defined as: free of caries associated with restoration.
Time frame: 2 years
Population: * 21 Subjects with 2 paired restorations (21 R, 21 F).~* 48 Subjects with a single restoration (23 R, 25 F).~* In Total: 69 subjects, 90 restorations.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ChemFil Rock Restoration (R) | Caries Incidence Associated With Restoration | Caries free restorations | 40 Restoration |
| ChemFil Rock Restoration (R) | Caries Incidence Associated With Restoration | Restorations with caries | 4 Restoration |
| Fuji IX Restoration (F) | Caries Incidence Associated With Restoration | Caries free restorations | 39 Restoration |
| Fuji IX Restoration (F) | Caries Incidence Associated With Restoration | Restorations with caries | 7 Restoration |
p-value: 0.523Fisher Exact
Secondary
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.
Time frame: 2 years
Population: * 21 Subjects with 2 paired restorations (21 R, 21 F).~* 48 Subjects with a single restoration (23 R, 25 F).
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ChemFil Rock Restoration (R) | Restored Tooth Performance | In need of repair/management | 0 Restored tooth |
| ChemFil Rock Restoration (R) | Restored Tooth Performance | Clinically successful | 44 Restored tooth |
| Fuji IX Restoration (F) | Restored Tooth Performance | Clinically successful | 45 Restored tooth |
| Fuji IX Restoration (F) | Restored Tooth Performance | In need of repair/management | 1 Restored tooth |
p-value: 0.1Fisher Exact