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Quaternary Ammonium Methacryloxy Silicate-containing Acrylic Resin

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ClinicalTrials.gov Identifier: NCT02525458
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
Wuhan University
Washington University School of Medicine
Fourth Military Medical University
Tongji Hospital
Augusta University
Information provided by (Responsible Party):
Frank Tay, BDSc (Hons), PhD, Kimmerling Holdings Group, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Oral Health Device: QAMS-containing PMMA Device: QAMS-free PMMA Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Antimicrobial Activity of a Quaternary Ammonium Methacryloxy Silicate-containing Acrylic Resin: A Randomized Clinical Trial
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: QAMS-containing PMMA
PMMA containing 5% QAMS
 Device: QAMS-containing PMMA
Wear retainer with QMAS-containing PMMA on one side of retainer
Placebo Comparator: QAMS-free PMMA
PMMA containing 0% QAMS
 Device: QAMS-free PMMA
Wear retainer with QMAS-free PMMA on other side of retainer


Outcome Measures
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Primary Outcome Measures :
  1. Biofilm killing efficacy within the biovolume (3D) and biomass (2D) of multi-species biofilms measured by confocal laser scanning microscopy and image analysis [ Time Frame: 48 hours ]
    Percentage kill of microorganisms ranging from 0% (no kill) to 100% (complete eradication of microorganisms within biofilm)


Secondary Outcome Measures :
  1. Redness, inflammation, ulceration or swelling of oral mucosa [ Time Frame: 48 hours ]
    Adverse effects in the form of redness, inflammation, ulceration or swelling of oral mucosa


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individual with no history or presence of a systemic disease
  • Absence of active caries or periodontal disease with pocket depths deeper than 4 mm

Exclusion Criteria:

  • Extensive gag reflex that precludes taking of an intraoral alginate impression
  • Presence of cleft palate that precludes the wearing of a Hawley retainer
  • Have been using an antimicrobial mouthwash prior to enrolment in the study
  • Have been taking antibiotics against infectious diseases in the half year preceding the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525458


Locations
China, Hubei
School and Hospital of Stomatology, Wuhan University
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Frank Tay, BDSc (Hons), PhD
Wuhan University
Washington University School of Medicine
Fourth Military Medical University
Tongji Hospital
Augusta University
Investigators
Study Director: Siying Liu, PhD School & Hospital of Stomatology, Wuhan University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Statistical Brief #368. Agency for Healthcare Research and Quality, Rockville, MD.  This link exits the ClinicalTrials.gov site
25. U. S. Food and Drug Administration. 510(k) premarket notification  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Frank Tay, BDSc (Hons), PhD, Doctor, Kimmerling Holdings Group, LLC
ClinicalTrials.gov Identifier: NCT02525458     History of Changes
Other Study ID Numbers: QAMS-2015
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Frank Tay, BDSc (Hons), PhD, Kimmerling Holdings Group, LLC:
antimicrobial
biofilms
acrylic resin
polymethyl methacrylate
 confocal laser scanning microscopy
split-mouth design
quaternary ammonium methacryloxy silicate

Additional relevant MeSH terms:
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs