An interventional study of UDMA-K18 smooth surface sealant in Dental Caries, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 12 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention
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.
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).
Exclusion Criteria:
UDMA-K18 smooth surface sealant
Device: UDMA-K18 smooth surface sealant
UDMA smooth surface sealant without K18
Device: UDMA-K18 smooth surface sealant
No intervention to provide baseline
The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
Also known as: UDMA-control
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.
White Spot Lesion (WSL) Index
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
Time frame: Visit Window: 3-4 weeks.
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.
| Milestone | All Participants |
|---|---|
| Started | 16 |
| Udma-k18 | 12 |
| Adhesive control | 12 |
| Udma-control | 9 |
| Completed | 9 |
| Not completed | 7 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Patient did not have teeth extracted | 1 |
| Withdrew: Teeth not sent to the lab or participant only had two teeth for extraction | 3 |
The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent.
| Canary Number | UDMA-K18 | UDMA-control | Adhesive Control |
|---|---|---|---|
| Change in Mineral Density Determined by the Canary Caries Detection System | 23.424 ± 3.288 | 31.125 ± 4.275 | 35.563 ± 7.378 |
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
| White spot Index | UDMA-K18 | UDMA-control | Adhesive Control |
|---|---|---|---|
| White Spot Lesion (WSL) Index | 0 (0 to 2) | 2 (0 to 2) | 2 (1 to 3) |
Collected over 10 Months, January 2018 to October 2018. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UDMA-K18 | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| UDMA-control | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Adhesive Control | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(Years) | All Participants |
|---|---|
| Age | 13.8 ± 2.3 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 8 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 16 |
| Canary Score(Canary Numbers) | All Participants |
|---|---|
| Mean | 7 (0 to 15) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The COMIRB approval and the consent forms specify that we cannot share PHI except as mandated by law. Therefore we do not intend to share any IPD to other researchers.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver