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Radiographic Progression of Infiltrated Caries Lesions In-vivo (ICON)

This study has been completed.
Sponsor:
Collaborator:
DMG Dental Material Gesellschaft mbH
Information provided by (Responsible Party):
Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01496456
First received: December 9, 2011
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: February 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dental Caries
Interventions: Device: Resin infiltration
Behavioral: Caries management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was not as expected and halted after one year. Local options to enhance patient accrual were exhausted. The total patient pool was small, but of sufficient scientific value to continue and complete the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Paired, split-mouth study design: Each patient received at least 1 pair of 2 treatments (one of each arm). Eligible tooth pairs selected for similarity. Random allocation of treatment to study teeth of each tooth pair.

Reporting Groups
  Description
Lesion Infiltration and Preventative Management Only

Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).

A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.

––– Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements.


Participant Flow:   Overall Study
    Lesion Infiltration and Preventative Management Only
STARTED   17 
Baseline   16 [1] 
1-yr Recall   12 
2-yr Recall   10 
3-yr Final Recall   9 
COMPLETED   9 
NOT COMPLETED   8 
Protocol Violation                1 
Lost to Follow-up                7 
[1] Baseline group started with 16 patients.



  Baseline Characteristics
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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.
Enrolled: 17 patients; 1 patient was not treated according to protocol. Baseline: 16 patients with 22 tooth pairs.

Reporting Groups
  Description
Lesion Infiltration and Preventative Management Only

Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only

SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements


Baseline Measures
   Lesion Infiltration and Preventative Management Only 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
 
<=18 years   8 
Between 18 and 65 years   8 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.1  (7.1) 
Gender 
[Units: Participants]
 
Female   12 
Male   4 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   2 
Not Hispanic or Latino   14 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   12 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures
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1.  Primary:   Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)   [ Time Frame: Baseline through 3 years ]

2.  Secondary:   Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories   [ Time Frame: Baseline through 3 years ]

3.  Secondary:   Lesion Survival After 3 Years   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Small number of subjects analyzed.


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


Results Point of Contact:  
Name/Title: Dr. Mathilde C Peters
Organization: UMichigan
phone: 734.925.2750
e-mail: mcpete@umich.edu


Publications of Results:
Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.
Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment - 2YR Results. J Dent Res 93(Spec Iss A):161, 2014.
Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.


Responsible Party: Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01496456     History of Changes
Other Study ID Numbers: PG#N010508
10-PAF03721 ( Other Identifier: U-Michigan )
Study First Received: December 9, 2011
Results First Received: February 17, 2016
Last Updated: July 12, 2016
Health Authority: United States: Institutional Review Board