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Trial record 2 of 4435 for:    ROCK

High-strength Glass-ionomer Dental Restorations (ROCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01523613
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborators:
Mott Children's Health Center
Dentsply International
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dental Caries
Interventions Device: Chemfil ROCK Glassionomer restoration
Device: Fuji IX GP Extra Glassionomer restoration
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ChemFil Rock Restoration (R) Fuji IX Restoration (F) Paired Restorations (Rock + Fuji)
Hide Arm/Group Description 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) 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). 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.
Period Title: Overall Study
Number of participants Number of units (Restorations) Number of participants Number of units (Restorations) Number of participants Number of units (Restorations)
Started 30 [1] 30 30 [2] 30 33 [3] 66
Completed 23 [4] 23 25 [5] 25 21 [6] 42
Not Completed 7 7 5 5 12 24
[1]
- 30 single restorations (30 R)
[2]
- 30 single restorations (30 F)
[3]
- 66 paired restorations (33R + 33F)
[4]
- 23 single restorations (23R)
[5]
- 25 single restorations (25F)
[6]
- 42 paired restorations (21R and 21F)
Arm/Group Title ChemFil Rock Restoration (R-single) Fuji IX Restoration (F-single) Paired Restorations (1R and 1F) Total
Hide Arm/Group Description 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) 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). 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 of all reporting groups
Overall Number of Baseline Participants 30 30 33 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 33 participants 93 participants
<=18 years
30
 100.0%
30
 100.0%
33
 100.0%
93
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 33 participants 93 participants
Female
20
  66.7%
15
  50.0%
21
  63.6%
56
  60.2%
Male
10
  33.3%
15
  50.0%
12
  36.4%
37
  39.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 33 participants 93 participants
Hispanic or Latino
2
   6.7%
4
  13.3%
7
  21.2%
13
  14.0%
Not Hispanic or Latino
28
  93.3%
26
  86.7%
26
  78.8%
80
  86.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 33 participants 93 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  73.3%
15
  50.0%
22
  66.7%
59
  63.4%
White
8
  26.7%
15
  50.0%
11
  33.3%
34
  36.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 33 participants 93 participants
30
 100.0%
30
 100.0%
33
 100.0%
93
 100.0%
1.Primary Outcome
Title Survival Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
  • 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/Group Title ChemFil Rock Restoration (R) Fuji IX Restoration (F)
Hide Arm/Group Description:
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)
Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
Overall Number of Participants Analyzed 44 46
Overall Number of Units Analyzed
Type of Units Analyzed: Restorations
44 46
Count of Units
Unit of Measure: Restorations
Clinically successful
39
  88.6%
44
  95.7%
Replaced due to fracture
5
  11.4%
2
   4.3%
Replaced due to loss of retention
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChemFil Rock Restoration (R), Fuji IX Restoration (F)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.262
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Caries Incidence Associated With Restoration
Hide Description - "Caries free restorations" is defined as: free of caries associated with restoration.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
  • 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/Group Title ChemFil Rock Restoration (R) Fuji IX Restoration (F)
Hide Arm/Group Description:
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)
Dental restoration made of Fuji IX GP Extra, used with Cavity Conditioner and application of GC-Coat Plus
Overall Number of Participants Analyzed 44 46
Overall Number of Units Analyzed
Type of Units Analyzed: Restoration
44 46
Count of Units
Unit of Measure: Restoration
Caries free restorations
40
  90.9%
39
  84.8%
Restorations with caries
4
   9.1%
7
  15.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChemFil Rock Restoration (R), Fuji IX Restoration (F)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Restored Tooth Performance
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
  • 21 Subjects with 2 paired restorations (21 R, 21 F).
  • 48 Subjects with a single restoration (23 R, 25 F).
Arm/Group Title Rock-restored Tooth (R-tooth) Fuji-restored Tooth (F-tooth)
Hide Arm/Group Description:
Tooth restored with a ChemFil Rock filling.
Tooth restored with a Fuji IX GP Extra filling.
Overall Number of Participants Analyzed 44 46
Overall Number of Units Analyzed
Type of Units Analyzed: Restored tooth
44 46
Count of Units
Unit of Measure: Restored tooth
Clinically successful
44
 100.0%
45
  97.8%
In need of repair/management
0
   0.0%
1
   2.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rock-restored Tooth (R-tooth), Fuji-restored Tooth (F-tooth)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 2 years (up to 26 months in individual cases)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rock-restored Tooth (R-tooth) Fuji-restored (F-tooth)
Hide Arm/Group Description Tooth restored with a ChemFil Rock filling. Tooth restored with a Fuji IX GP Extra filling.
All-Cause Mortality
Rock-restored Tooth (R-tooth) Fuji-restored (F-tooth)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%) 
Hide Serious Adverse Events
Rock-restored Tooth (R-tooth) Fuji-restored (F-tooth)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rock-restored Tooth (R-tooth) Fuji-restored (F-tooth)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   0/63 (0.00%) 
Current study was not designed to investigate wear behavior as final surface treatment was different between the two materials.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mathilde Peters
Organization: University of Michigan
EMail: mcpete@umich.edu
Layout table for additonal information
Responsible Party: Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01523613    
Other Study ID Numbers: N013822
11-PAF05343 ( Other Identifier: U-Michigan )
First Submitted: January 27, 2012
First Posted: February 1, 2012
Results First Submitted: July 15, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017