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Trial record 40 of 1201 for:    tooth decay

Resin Infiltration to Arrest Early Tooth Decay

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ClinicalTrials.gov Identifier: NCT01584024
Recruitment Status : Completed
First Posted : April 24, 2012
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
DMG Dental Material Gesellschaft mbH
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: Resin infiltration
Device: Sham treatment
Enrollment 42
Recruitment Details Caries-active volunteer cadet-candidates and cadets, at high risk for caries disease, were recruited at United States Military Academy in West-Point, New York (USA).
Pre-assignment Details Paired, split-mouth study design: Each patient received 2 paired treatments (one of each arm). Eligible tooth pairs were selected for similarity. Random allocation of treatment to study lesions per tooth pair.
Arm/Group Title Participants With Paired Lesions: Resin Infiltration / Control
Hide Arm/Group Description

Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).

Resin infiltration (test) or Sham Treatment (control) of two paired carious lesions in addition to preventative measures and behavioral modification.

Period Title: Overall Study
Number of participants Number of units (Lesions)
Started 42 84
Completed 29 58
Not Completed 13 26
Reason Not Completed
Lost to Follow-up             10            
Withdrawal by Subject             3            
Arm/Group Title Participants With Paired Lesions: Resin Infiltration / Control
Hide Arm/Group Description Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).
Overall Number of Baseline Participants 42
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
84
Hide Baseline Analysis Population Description
Analysis populations are single and paired lesions
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
42
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
20.1  (0.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
2
   4.8%
Male
40
  95.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
4
   9.5%
Not Hispanic or Latino
38
  90.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.4%
Native Hawaiian or Other Pacific Islander
2
   4.8%
Black or African American
11
  26.2%
White
28
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
 100.0%
Number of Lesions with Progression   [1] 
Count of Units
Unit of measure:  Lesions
Number Analyzed 84 Lesions
58
  69.0%
[1]
Measure Description: Lesion progression is measured by assessment of single radiographs (using depth categories) and pairwise comparison of radiographs over time (continuous progression)
1.Primary Outcome
Title Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
Hide Description Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resin Infiltration Control
Hide Arm/Group Description:
Resin infiltration of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
Sham treatment of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
Overall Number of Participants Analyzed 29 29
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
29 29
Count of Units
Unit of Measure: Lesions
4
  13.8%
14
  48.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resin Infiltration, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Number of Lesions With Progression as Measured by Depth Category (N=Lesions)
Hide Description Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).
Time Frame 3 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resin Infiltration Control
Hide Arm/Group Description:
Resin infiltration of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
Sham treatment of lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish)
Overall Number of Participants Analyzed 29 29
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
29 29
Count of Units
Unit of Measure: Lesions
3
  10.3%
7
  24.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resin Infiltration, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.17
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Time Frame Baseline through 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With Paired Lesions: Resin Infiltration / Control
Hide Arm/Group Description Within-person study: both arms were applied in same participant (2 study teeth/lesions per person).
All-Cause Mortality
Participants With Paired Lesions: Resin Infiltration / Control
Affected / at Risk (%)
Total   0/42 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Paired Lesions: Resin Infiltration / Control
Affected / at Risk (%)
Total   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Paired Lesions: Resin Infiltration / Control
Affected / at Risk (%)
Total   0/42 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Mathilde Peters (PI)
Organization: University of Michigan
Phone: 734-925-2750
Responsible Party: Mathilde Peters, DMD, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01584024     History of Changes
Other Study ID Numbers: N010508-S3
12-PAF02598 ( Other Identifier: U-Michigan )
First Submitted: April 20, 2012
First Posted: April 24, 2012
Results First Submitted: December 22, 2018
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019