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Trial Outcomes & Findings for High-strength Glass-ionomer Dental Restorations (NCT NCT01523613)

NCT ID: NCT01523613

Last Updated: 2017-10-03

Results Overview

* 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

2 years

Results posted on

2017-10-03

Participant Flow

Unit of analysis: Restorations

Participant milestones

Participant milestones
Measure
ChemFil Rock Restoration (R)
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)
Fuji IX Restoration (F)
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).
Paired Restorations (Rock + Fuji)
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.
Overall Study
STARTED
30 30
30 30
33 66
Overall Study
COMPLETED
23 23
25 25
21 42
Overall Study
NOT COMPLETED
7 7
5 5
12 24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High-strength Glass-ionomer Dental Restorations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ChemFil Rock Restoration (R-single)
n=30 Participants
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)
Fuji IX Restoration (F-single)
n=30 Participants
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).
Paired Restorations (1R and 1F)
n=33 Participants
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.
Total
n=93 Participants
Total of all reporting groups
Age, Categorical
<=18 years
30 Participants
n=5 Participants
30 Participants
n=7 Participants
33 Participants
n=5 Participants
93 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
15 Participants
n=7 Participants
21 Participants
n=5 Participants
56 Participants
n=4 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
15 Participants
n=7 Participants
12 Participants
n=5 Participants
37 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
13 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=5 Participants
26 Participants
n=7 Participants
26 Participants
n=5 Participants
80 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
22 Participants
n=5 Participants
15 Participants
n=7 Participants
22 Participants
n=5 Participants
59 Participants
n=4 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
15 Participants
n=7 Participants
11 Participants
n=5 Participants
34 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
30 Participants
n=5 Participants
30 Participants
n=7 Participants
33 Participants
n=5 Participants
93 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 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.

* 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.

Outcome measures

Outcome measures
Measure
ChemFil Rock Restoration (R)
n=44 Restorations
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)
Fuji IX Restoration (F)
n=46 Restorations
Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
Survival Rate
Clinically successful
39 Restorations
44 Restorations
Survival Rate
Replaced due to fracture
5 Restorations
2 Restorations
Survival Rate
Replaced due to loss of retention
0 Restorations
0 Restorations

SECONDARY outcome

Timeframe: 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.

\- "Caries free restorations" is defined as: free of caries associated with restoration.

Outcome measures

Outcome measures
Measure
ChemFil Rock Restoration (R)
n=44 Restoration
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)
Fuji IX Restoration (F)
n=46 Restoration
Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
Caries Incidence Associated With Restoration
Caries free restorations
40 Restoration
39 Restoration
Caries Incidence Associated With Restoration
Restorations with caries
4 Restoration
7 Restoration

SECONDARY outcome

Timeframe: 2 years

Population: * 21 Subjects with 2 paired restorations (21 R, 21 F). * 48 Subjects with a single restoration (23 R, 25 F).

* 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.

Outcome measures

Outcome measures
Measure
ChemFil Rock Restoration (R)
n=44 Restored tooth
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)
Fuji IX Restoration (F)
n=46 Restored tooth
Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
Restored Tooth Performance
Clinically successful
44 Restored tooth
45 Restored tooth
Restored Tooth Performance
In need of repair/management
0 Restored tooth
1 Restored tooth

Adverse Events

Rock-restored Tooth (R-tooth)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fuji-restored (F-tooth)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mathilde Peters

University of Michigan

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place