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MI Varnish for the Prevention of White Spot Lesions

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ClinicalTrials.gov Identifier: NCT03446690
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chung How Kau, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions White Spot Lesion
Orthodontic Treatment
Interventions Drug: MI Varnish
Other: Control group
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MI Varnish Group Control Group
Hide Arm/Group Description

33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. 29 subjects were recruited retrospectively from a previous study and the results compared.

MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.

A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.

Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.

Period Title: Overall Study
Started 33 29
Completed 26 29
Not Completed 7 0
Arm/Group Title MI Varnish Group Control Group Total
Hide Arm/Group Description 33 subjects were prospectively recruited for the project in the MI Varnish group. All subjects will be patients seeking orthodontic treatment at the Department of Orthodontics, UAB. A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. All subjects were patients seeking orthodontic treatment at the Department of Orthodontics, School of Dentistry, University of Alabama at Birmingham. Total of all reporting groups
Overall Number of Baseline Participants 26 29 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 29 participants 55 participants
29.5  (6.7) 28.5  (5.2) 29  (5.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
Female
16
  61.5%
16
  55.2%
32
  58.2%
Male
10
  38.5%
13
  44.8%
23
  41.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 29 participants 55 participants
Central America
18
  69.2%
20
  69.0%
38
  69.1%
Africa
6
  23.1%
9
  31.0%
15
  27.3%
China
2
   7.7%
0
   0.0%
2
   3.6%
1.Primary Outcome
Title Enamel Decalcification Index (EDI) Scores
Hide Description Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.
Time Frame Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MI Varnish Group Control Group
Hide Arm/Group Description:
33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.

A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.

Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.

Overall Number of Participants Analyzed 26 29
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
Total EDI score of 1-month visit
1.038
(0.268 to 1.809)
1
(0.382 to 1.618)
Total EDI score of 2-month visit
1.308
(0.138 to 2.477)
2.724
(0.769 to 4.679)
Total EDI score of 3-month visit
1.923
(0.382 to 3.464)
3.966
(1.662 to 6.269)
Total EDI score of 4-month visit
2.692
(0.778 to 4.607)
5.897
(3.028 to 8.765)
Time Frame During and within 6 months from the end of the treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MI Varnish Group Control Group
Hide Arm/Group Description 33 subjects were initially recruited in the study for MI Varnish. 7 subjects failed to return or did not meet the study protocol. MI Varnish were applied on their teeth initially for 4 weeks (twice) and then 3 monthly intervals.

A control group was comprised of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. No intervention for this group.

Control group: Participants received routine treatment and oral hygiene regimes. No intervention for this group.

All-Cause Mortality
MI Varnish Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MI Varnish Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MI Varnish Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/29 (0.00%) 
We attempt to overcome the compliance barrier giving the patients brushing technique instructions as a control of their actual compliance with the protocol. However it was observed plaque accumulation and gingival inflammation on some patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chung How Kau
Organization: University of Alabama at Birmingham
Phone: 205-934-1289
EMail: ckau@uab.edu
Responsible Party: Chung How Kau, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03446690     History of Changes
Other Study ID Numbers: 1135815
First Submitted: February 14, 2018
First Posted: February 27, 2018
Results First Submitted: March 16, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018