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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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Restorations)

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    ChemFil Rock Restoration (R)   Fuji IX Restoration (F)   Paired Restorations (Rock + Fuji)
Participants Units (Restorations) Participants Units (Restorations) Participants 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      5      12    
[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)



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)
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).
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.
Total Total of all reporting groups

Baseline Measures
   ChemFil Rock Restoration (R-single)   Fuji IX Restoration (F-single)   Paired Restorations (1R and 1F)   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   33   93 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
United States   30   30   33   93 


  Outcome Measures

1.  Primary:   Survival Rate   [ Time Frame: 2 years ]

2.  Secondary:   Caries Incidence Associated With Restoration   [ Time Frame: 2 years ]

3.  Secondary:   Restored Tooth Performance   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Current study was not designed to investigate wear behavior as final surface treatment was different between the two materials.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mathilde Peters
Organization: University of Michigan
e-mail: mcpete@umich.edu



Responsible Party: Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01523613     History of Changes
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