Quaternary Ammonium Methacryloxy Silicate-containing Acrylic Resin

NCT02525458 | Completed Phase 2 DMC

• 1 other identifier: QAMS-2015
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Keywords

antimicrobial; biofilms; acrylic resin; polymethyl methacrylate; confocal laser scanning microscopy; split-mouth design; quaternary ammonium methacryloxy silicate

Outcome Measures

Primary Outcomes (1)

• Biofilm killing efficacy within the biovolume (3D) and biomass (2D) of multi-species biofilms measured by confocal laser scanning microscopy and image analysis

  Percentage kill of microorganisms ranging from 0% (no kill) to 100% (complete eradication of microorganisms within biofilm)

  48 hours

Secondary Outcomes (1)

• Redness, inflammation, ulceration or swelling of oral mucosa

  48 hours

Study Arms (2)

QAMS-containing PMMA

EXPERIMENTAL

PMMA containing 5% QAMS

Device: QAMS-containing PMMA

QAMS-free PMMA

PLACEBO COMPARATOR

PMMA containing 0% QAMS

Device: QAMS-free PMMA

Interventions

QAMS-containing PMMA DEVICE

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

QAMS-containing PMMA

QAMS-free PMMA DEVICE

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

QAMS-free PMMA

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank Tay, BDSc (Hons), PhD: lead
• Wuhan University: collaborator
• Washington University School of Medicine: collaborator
• Air Force Military Medical University, China: collaborator
• Tongji Hospital: collaborator
• Augusta University: collaborator

Study Sites (1)

School and Hospital of Stomatology, Wuhan University

Wuhan, Hubei, 430000, China

Location

Related Publications (32)

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Related Links

• Statistical Brief #368. Agency for Healthcare Research and Quality, Rockville, MD.
• 25\. U. S. Food and Drug Administration. 510(k) premarket notification

Study Officials

• Siying Liu, PhD

  School & Hospital of Stomatology, Wuhan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 9, 2015
• First Posted: August 17, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

CN (1)