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Quaternary Ammonium Methacryloxy Silicate-containing Acrylic Resin

NCT02525458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-08-30

No results posted yet for this study

Summary

One of the major challenges in orthodontic treatment is long-term stability. Because removable retainers are worn for at least one year, bacteria and fungi may accumulate on the retainers in the form of multi-species plaque biofilms. This may result in increased incidence of proximal dental caries or oral candida infection. Thus, incorporation of antimicrobial activity in orthodontic acrylic resin to achieve plaque biofilm reduction is highly desirable. An antimicrobial and antifungal quaternary ammonium methacryloxy silicate molecule (QAMS) has been synthesized by sol-gel reaction and incorporated into orthodontic acrylic resin. The QAMS-copolymerized acrylic resin demonstrated contact-killing properties against single-species biofilms in previous in vitro studies and has received US FDA 510(K) clearance for marketing. The objective of the present randomized clinical trial is to determine the in vivo antimicrobial efficacy of the QAMS-containing orthodontic acrylic by using removable retainers that are worn by recruited subjects to create 48-hour multi-species plaque biofilms. The null hypothesis tested is that there is no difference in the antimicrobial activities between QAMS-free and QAMS-containing orthodontic acrylic resin on oral biofilms grown in vivo in human subjects.

Conditions

  • Oral Health

Interventions

DEVICE

QAMS-containing PMMA

Wear retainer with QMAS-containing PMMA on one side of retainer

DEVICE

QAMS-free PMMA

Wear retainer with QMAS-free PMMA on other side of retainer

Sponsors & Collaborators

  • Wuhan University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Air Force Military Medical University, China

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Augusta University

    collaborator OTHER

  • Frank Tay, BDSc (Hons), PhD

    lead OTHER

Principal Investigators

  • Siying Liu, PhD · School & Hospital of Stomatology, Wuhan University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-10-31
Completion
2016-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02525458 on ClinicalTrials.gov