Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant
Study Details
Study Description
Brief Summary
This study will evaluate effectiveness of a urethane dimethacrylate (UDMA)-quaternary ammonium methacrylate (K18) resin (UDMA-K18) smooth surface sealant to prevent biofilm attachment to tooth surfaces thereby eliminating the possibility for the tooth to be demineralized. The hypothesis is that UDMA-K18 containing smooth surface sealant will be more effective at reducing enamel demineralization than the UDMA control or no treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Esthetics is a motivating factor to seek orthodontic treatment. However, if oral hygiene is inadequate during fixed appliance wear, unsightly white spot lesions (WSL) may develop. WSLs are areas of enamel demineralization that develop due to microbial assault that manifest as white, chalky opacity on the enamel. Urethane dimethacrylate (UDMA) can be modified to produce an antimicrobial compound, UDMA-K18, that has been proven to decrease microbial attachment in-vitro. (Sticker 2016) The use of a UDMA-K18 containing sealant may help to eliminate the development of WSLs around orthodontic brackets.
This study will place experimental or control smooth surface resins on teeth that are scheduled to be extracted for orthodontic reasons. These teeth are typically bicuspids that are to be extracted to create room for the orthodontic movement of teeth. These teeth are usually not extracted at the advent of first orthodontic bracket bonding but are extracted about 30 days later. The design of this study is to place sealants on those teeth (or as control, no sealant) and evaluate the teeth after they have been extracted.
Design: The study is a prospective, paired randomized control trial for which treatment (no sealant, UDMA-control, or UDMA-K18 sealant) will be applied clinically and evaluated on extracted teeth in laboratory conditions.
Procedures: Before bonding, one premolar per patient will be assigned to a group. The group each premolar is assigned to will be determined by a randomized, computer generated program. The allocation will be concealed in an opaque envelope that will be opened at the time of initial bonding. If a fourth premolar is planned for extraction, a random selection of the treatments will be selected in a 1:1:1 ratio and this treatment will be applied to the fourth premolar.
At the time of initial bonding, the UDMA and UDMA-K18 sealant will be applied to the selected premolar following manufacturer instructions. Briefly, the clinician will isolate the teeth using the NOLA Dry Field System and excess saliva will be removed by drying the teeth with an air-water syringe. In the treatment group, 37 % Phosphoric Acid will be applied to the entire buccal surface for 30 seconds, rinsed, and dried. Next, the assigned sealant will be evenly applied to the entire buccal surface of the premolar and light cured. The sealant which is adhesive will be applied to the bracket pad and the bracket pad will be pushed to place, excess cement will be removed and light cured.
In the control group, 37 % Phosphoric Acid will be applied for 30 seconds strictly to the area where the bracket will be bonded on the buccal surface, rinsed, and dried. No sealant will be applied. The adhesive sealant will be applied to the bracket pad and the bracket pad will be pushed to place, excess cement will be removed and light cured. After 3-6 weeks, the patient will have their premolars extracted. After extraction they will be placed in a Tooth Storage Solution (25 % ethanol, 75 % water with the addition of saturated hydroxyapatite, 20 mg of NaN3, and 40 mg Thymol) that is antimicrobial and does not alter the tooth surface. These teeth will be collected by the investigators for histologic study.
The collected, extracted teeth will be sectioned using a water-cooled, Buhler slow speed diamond saw in three 2mm sections through the bracket base. A polarized light microscopy (PLM) digitized photograph of the cross-sectional sample will be analyzed to determine the depth of lesions, if present. The mineral density profile will be analyzed using contact micro radiography (TMR).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: UDMA-K18 UDMA-K18 smooth surface sealant |
Device: UDMA-K18 smooth surface sealant
The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
Other Names:
|
Placebo Comparator: UDMA-control UDMA smooth surface sealant without K18 |
Device: UDMA-K18 smooth surface sealant
The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
Other Names:
|
No Intervention: Negative control No intervention to provide baseline |
Outcome Measures
Primary Outcome Measures
- Change in Mineral Density Determined by the Canary Caries Detection System [Visit Window: 3-4 weeks.]
The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent.
Secondary Outcome Measures
- White Spot Lesion (WSL) Index [Visit Window: 3-4 weeks.]
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Orthodontic patients at the Department of Orthodontics Clinic, School of Dental Medicine, University of Colorado who agree to consent to this study.
-
Orthodontic treatment plans that include fixed appliances from the second premolar to second premolar in both arches.
-
Orthodontic treatment plans that include extractions of at least 3 bicuspids at about 1 month after bracket placement.
-
The patient has adequate oral hygiene
Exclusion Criteria:
-
Evidence of decalcification or restorations on any of the premolars planned for extraction prior to orthodontic treatment,
-
Pregnant women (self reported)
-
Any condition that contraindicates orthodontic treatment,
-
Not willing to consent to the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Colorado, School of Dental Medicine | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- University of Colorado School of Dental Medicine
Investigators
- Principal Investigator: Clifton Carey, PhD, Professor, Dir Translational Research, University of Colorado, School of Dental Medicine
Study Documents (Full-Text)
More Information
Publications
- Gong SQ, Niu LN, Kemp LK, Yiu CK, Ryou H, Qi YP, Blizzard JD, Nikonov S, Brackett MG, Messer RL, Wu CD, Mao J, Bryan Brister L, Rueggeberg FA, Arola DD, Pashley DH, Tay FR. Quaternary ammonium silane-functionalized, methacrylate resin composition with antimicrobial activities and self-repair potential. Acta Biomater. 2012 Sep;8(9):3270-82. doi: 10.1016/j.actbio.2012.05.031. Epub 2012 May 29.
- Liu SY, Tonggu L, Niu LN, Gong SQ, Fan B, Wang L, Zhao JH, Huang C, Pashley DH, Tay FR. Antimicrobial activity of a quaternary ammonium methacryloxy silicate-containing acrylic resin: a randomised clinical trial. Sci Rep. 2016 Feb 23;6:21882. doi: 10.1038/srep21882.
- Schmuck BD, Carey CM. Improved Contact X-Ray Microradiographic Method to Measure Mineral Density of Hard Dental Tissues. J Res Natl Inst Stand Technol. 2010 Apr 1;115(2):75-83. Print 2010 Mar-Apr.
- Wefel JS, Harless JD. Comparison of artificial white spots by microradiography and polarized light microscopy. J Dent Res. 1984 Nov;63(11):1271-5.
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Study Results
Participant Flow
Recruitment Details | Recruitment began in January 2018 and ended in October 2018. Participants were recruited from the patient pool at the University of Colorado School of Dental Medicine Department of Orthodontics. Eligible candidates were offered the opportunity to participate in the study. |
---|---|
Pre-assignment Detail | Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. Enrolled participants were assigned to receive up to all three treatments. There were 16 participant total. Treatments included: UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. |
Period Title: Overall Study | |
STARTED | 16 |
UDMA-K18 | 12 |
Adhesive Control | 12 |
UDMA-control | 9 |
COMPLETED | 9 |
NOT COMPLETED | 7 |
Baseline Characteristics
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | Participants were enrolled into the study if they met the inclusion criteria of having a planned orthodontic therapy that required extraction of at least 2 teeth and that those teeth were free of demineralization and did not have restorations. All 16 participants had all three treatments. Thus there were 16 participant total. Treatments included: UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. The adhesive used to bond the orthodontic bracket to the tooth UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. |
Overall Participants | 16 |
Age (Years) [Mean (Standard Deviation) ] | |
Age |
13.8
(2.3)
|
Sex: Female, Male (Count of Participants) | |
Female |
8
50%
|
Male |
8
50%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
11
68.8%
|
Not Hispanic or Latino |
5
31.3%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
16
100%
|
Canary Score (Canary Numbers) [Mean (Full Range) ] | |
Mean (Full Range) [Canary Numbers] |
7
|
Outcome Measures
Title | Change in Mineral Density Determined by the Canary Caries Detection System |
---|---|
Description | The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent. |
Time Frame | Visit Window: 3-4 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
In this split mouth (same mouth) design all participants receive all treatments. |
Arm/Group Title | UDMA-K18 | UDMA-control | Adhesive Control |
---|---|---|---|
Arm/Group Description | UDMA-K18 smooth surface sealant UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | UDMA smooth surface sealant without K18 UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | The adhesive used to bond the orthodontic bracket to the tooth |
Measure Participants | 12 | 9 | 12 |
Mean (Standard Deviation) [Canary Number] |
23.424
(3.288)
|
31.125
(4.275)
|
35.563
(7.378)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | UDMA-K18, Adhesive Control |
---|---|---|
Comments | Paired difference test within each participant. | |
Type of Statistical Test | Equivalence | |
Comments | The null hypothesis is that there are no significant paired differences between the groups. The power calculation is based on the observed variation and number of participants | |
Statistical Test of Hypothesis | p-Value | 0.0003 |
Comments | Paired difference p value comparing UDMA-K18 vs Adhesive Control | |
Method | Paired difference test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Paired difference t-test |
Estimated Value | -12.139 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Standard Deviation Value: 7.101 |
|
Estimation Comments | There are 12 participants (pairs) for this comparison |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | UDMA-K18, UDMA-control |
---|---|---|
Comments | Paired comparison | |
Type of Statistical Test | Equivalence | |
Comments | Null hypothesis was that there were no differences between the groups | |
Statistical Test of Hypothesis | p-Value | 0.0063 |
Comments | Paired differrnce between UDMA-K18 and UDMA control | |
Method | Paired difference test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Paired difference t-test |
Estimated Value | -7.412 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Standard Deviation Value: 6.049 |
|
Estimation Comments | There are 9 participant pairs for this comparison |
Title | White Spot Lesion (WSL) Index |
---|---|
Description | The WSL Index is from 0 (no lesion) to 4 (severe lesion) |
Time Frame | Visit Window: 3-4 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
Split mouth design : All participants received all treatments |
Arm/Group Title | UDMA-K18 | UDMA-control | Adhesive Control |
---|---|---|---|
Arm/Group Description | UDMA-K18 smooth surface sealant UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | UDMA smooth surface sealant without K18 UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | The adhesive used to bond the orthodontic bracket to the tooth |
Measure Participants | 12 | 9 | 12 |
Median (Full Range) [White spot Index] |
0
|
2
|
2
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | UDMA-K18, Adhesive Control |
---|---|---|
Comments | WSL Index is non-parametric | |
Type of Statistical Test | Equivalence | |
Comments | The Null hypothesis was that there would be no differences between the groups | |
Statistical Test of Hypothesis | p-Value | 0.0033 |
Comments | ||
Method | Chi-squared | |
Comments | ||
Method of Estimation | Estimation Parameter | Chi Square on WSL Index frequency |
Estimated Value | 15.77 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | UDMA-K18, UDMA-control |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | The null hypothesis was that there would not be any differences between the groups | |
Statistical Test of Hypothesis | p-Value | 0.1450 |
Comments | ||
Method | Chi-squared | |
Comments | ||
Method of Estimation | Estimation Parameter | Chi Square on WSL Index frequency |
Estimated Value | 6.8321 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | 10 Months, January 2018 to October 2018 | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Study participants were provided with a 24-hour hot line to call if they experienced any discomfort associated with the placement of the sealant or orthodontic bracket. | |||||
Arm/Group Title | UDMA-K18 | UDMA-control | Adhesive Control | |||
Arm/Group Description | UDMA-K18 smooth surface sealant UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | UDMA smooth surface sealant without K18 UDMA-K18 smooth surface sealant: The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | The adhesive used to bond the orthodontic bracket to the tooth | |||
All Cause Mortality |
||||||
UDMA-K18 | UDMA-control | Adhesive Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | |||
Serious Adverse Events |
||||||
UDMA-K18 | UDMA-control | Adhesive Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
UDMA-K18 | UDMA-control | Adhesive Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT 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 | Clifton Carey |
---|---|
Organization | University of Colorado, SoDM |
Phone | 3037241046 |
clifton.carey@cuanschutz.edu |
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