CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
QAMS-containing PMMA +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02525458
NCT02525458Phase 2Completed

Antimicrobial Activity of a Quaternary Ammonium Methacryloxy Silicate-containing Acrylic Resin: A Randomized Clinical Trial

Frank Tay, BDSc (Hons), PhD·interventional·Posted Aug 17, 2015·Updated Aug 30, 2016

In Brief

A Phase 2 clinical trial evaluating QAMS-containing PMMA and QAMS-free PMMA for Oral Health. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Health
CountriesChina

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 17, 2015
Enrollment StartJul 1, 2015
Primary CompletionOct 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.9 years ago

Interventions

QAMS-containing PMMAdevice

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

QAMS-free PMMAdevice

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