Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant

NCT03306433 | Completed Results FDA Device

• 1 other identifier: 17-0633
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

dental caries; white spot lesion; prevention; smooth surface sealant

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit Window: 3-4 weeks.

Secondary Outcomes (1)

• White Spot Lesion (WSL) Index

  Visit Window: 3-4 weeks.

Study Arms (3)

UDMA-K18

EXPERIMENTAL

UDMA-K18 smooth surface sealant

Device: UDMA-K18 smooth surface sealant

UDMA-control

PLACEBO COMPARATOR

UDMA smooth surface sealant without K18

Device: UDMA-K18 smooth surface sealant

Negative control

NO INTERVENTION

No intervention to provide baseline

Interventions

UDMA-K18 smooth surface sealant DEVICE

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

UDMA-K18; UDMA-control

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Colorado School of Dental Medicine: collaborator

Study Sites (1)

University of Colorado, School of Dental Medicine

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• 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.

  PMID: 21546983 BACKGROUND

• 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.

  PMID: 22659173 BACKGROUND

• 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.

  PMID: 26903314 BACKGROUND

• Wefel 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.

  PMID: 6094633 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Clifton Carey
• Organization: University of Colorado, SoDM

clifton.carey@cuanschutz.edu

3037241046

Study Officials

• Clifton Carey, PhD

  Professor, Dir Translational Research, University of Colorado, School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 11, 2017
• Study Start: January 8, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)