Dental Caries
Conditions
Keywords
dental caries, white spot lesion, prevention, smooth surface sealant
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.
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).
Interventions
DEVICEUDMA-K18 smooth surface sealant
The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
Sponsors
University of Colorado School of Dental Medicine
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The trial design is triple-blinded. The manufacturer will deliver the blinded treatments in identical bottles labelled A and B, therefore, neither the patient nor the clinician will know which treatment is rendered to each tooth. However, the no sealant control will not be blinded. Blinding will continue to be present during the histological portion of the experiment as the assessors will not be aware of which sealant was used to treat each tooth. After a blinded assessment, blinds will be lifted when between-group analysis is performed.
Intervention model description
prospective, paired randomized control trial for which treatment (no sealant, UDMA control, UDMA-K18 sealant) will be applied clinically and evaluated on extracted teeth in laboratory conditions.
Eligibility
Sex/Gender
ALL
Age
12 Years to 89 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| White Spot Lesion (WSL) Index | Visit Window: 3-4 weeks. | The WSL Index is from 0 (no lesion) to 4 (severe lesion) |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants 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. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Patient did not have teeth extracted | 1 |
| Overall Study | Teeth not sent to the lab or participant only had two teeth for extraction | 3 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous Age | 13.8 Years STANDARD_DEVIATION 2.3 |
| Canary Score | 7 Canary Numbers |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Change in Mineral Density Determined by the Canary Caries Detection System
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.
Population: In this split mouth (same mouth) design all participants receive all treatments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UDMA-K18 | Change in Mineral Density Determined by the Canary Caries Detection System | 23.424 Canary Number | Standard Deviation 3.288 |
| UDMA-control | Change in Mineral Density Determined by the Canary Caries Detection System | 31.125 Canary Number | Standard Deviation 4.275 |
| Adhesive Control | Change in Mineral Density Determined by the Canary Caries Detection System | 35.563 Canary Number | Standard Deviation 7.378 |
Comparison: Paired difference test within each participant.p-value: 0.0003Paired difference test, 2 sided
Comparison: Paired comparisonp-value: 0.0063Paired difference test, 2 sided
Secondary
White Spot Lesion (WSL) Index
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
Time frame: Visit Window: 3-4 weeks.
Population: Split mouth design : All participants received all treatments
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UDMA-K18 | White Spot Lesion (WSL) Index | 0 White spot Index |
| UDMA-control | White Spot Lesion (WSL) Index | 2 White spot Index |
| Adhesive Control | White Spot Lesion (WSL) Index | 2 White spot Index |
Comparison: WSL Index is non-parametricp-value: 0.0033Chi-squared
p-value: 0.145Chi-squared