Dental CariesK18NCT03306433
Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant
A study testing UDMA-K18 smooth surface sealant in people with Dental Caries, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- UDMA-K18 smooth surface sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 7 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, School of Dental Medicine
Aurora, Colorado, 80045
About this study
Official title: Prevention of Enamel Demineralization in Fixed Appliance Orthodontic Patients Using UDMA-K18 Sealant to Prevent Microbial Attachment Compared to a UDMA Control and no Sealant, a Randomized Split Mouth Clinical Trial
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.
Read the 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).
- Conditions
- Dental Caries
- Being tested
- UDMA-K18 smooth surface sealant
- Keywords
- dental caries, white spot lesion, prevention, smooth surface sealant
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UDMA-K18 smooth surface sealantDevice
Also called UDMA-control
The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
| Study group | Role | What they receive |
|---|---|---|
| UDMA-K18 | Experimental | UDMA-K18 smooth surface sealant Receives: Device: UDMA-K18 smooth surface sealant |
| UDMA-control | Placebo comparator | UDMA smooth surface sealant without K18 Receives: Device: UDMA-K18 smooth surface sealant |
| Negative control | No intervention | No intervention to provide baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit Window: 3-4 weeks.
Secondary outcomes (1)
White Spot Lesion (WSL) Index
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
Measured: Visit Window: 3-4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start8 Jan 2018
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado School of Dental Medicine
- Responsible party
- Sponsor
- Investigators
- Clifton Carey, PhD, Principal investigator, Professor, Dir Translational Research, University of Colorado, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306433
- Sponsor's protocol ID
- 17-0633
- Acronym
- K18
- Status last verified
- Sep 2021
- First submitted
- 5 Oct 2017
- Last updated
- 7 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
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. doi: 10.6028/jres.115.006. Print 2010 Mar-Apr.
PubMed 21546983Gong 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.
PubMed 22659173Liu 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.
PubMed 26903314Wefel JS, Harless JD. Comparison of artificial white spots by microradiography and polarized light microscopy. J Dent Res. 1984 Nov;63(11):1271-5. doi: 10.1177/00220345840630110301.
PubMed 6094633
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Enamel Demineralization in Fixed Appliance Orthodontic Patients Using UDMA-K18 Sealant to Prevent Microbial Attachment Compared to a UDMA Control and no Sealant, a Randomized Split Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT03306433
- Acronym / sponsor ID
- K18 / 17-0633
- Conditions
- Dental Caries
- Keywords
- dental caries, white spot lesion, prevention, smooth surface sealant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado School of Dental Medicine
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| UDMA-K18 | Experimental | Device: UDMA-K18 smooth surface sealantUDMA-K18 smooth surface sealant |
| UDMA-control | Placebo comparator | Device: UDMA-K18 smooth surface sealantUDMA smooth surface sealant without K18 |
| Negative control | No intervention | –No intervention to provide baseline |
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UDMA-K18 smooth surface sealantAlso: UDMA-controlThe K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface. | Device | UDMA-K18, UDMA-control |
Primary outcome
Change in Mineral Density Determined by the Canary Caries Detection System
Time frame: Visit Window: 3-4 weeks.
The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent.
1 secondary outcome
White Spot Lesion (WSL) Index
Time frame: Visit Window: 3-4 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21546983Schmuck 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. doi: 10.6028/jres.115.006. Print 2010 Mar-Apr.
- Background: PubMed 22659173Gong 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.
- Background: PubMed 26903314Liu 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.
- Background: PubMed 6094633Wefel JS, Harless JD. Comparison of artificial white spots by microradiography and polarized light microscopy. J Dent Res. 1984 Nov;63(11):1271-5. doi: 10.1177/00220345840630110301.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton Carey, PhD principal investigator
Professor, Dir Translational Research, University of Colorado, School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UDMA-K18 smooth surface sealant in people with Dental Caries, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mineral Density Determined by the Canary Caries Detection System (time frame: Visit Window: 3-4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306433, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.