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

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 |
Arm | Intervention/treatment |
---|---|
Experimental: QAMS-containing PMMA
PMMA containing 5% QAMS
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Device: QAMS-containing PMMA
Wear retainer with QMAS-containing PMMA on one side of retainer |
Placebo Comparator: QAMS-free PMMA
PMMA containing 0% QAMS
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Device: QAMS-free PMMA
Wear retainer with QMAS-free PMMA on other side of retainer |
- 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)
- 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

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

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
China, Hubei | |
School and Hospital of Stomatology, Wuhan University | |
Wuhan, Hubei, China, 430000 |
Study Director: | Siying Liu, PhD | School & Hospital of Stomatology, Wuhan University |
Publications:
Responsible Party: | Frank Tay, BDSc (Hons), PhD, Doctor, Kimmerling Holdings Group, LLC |
ClinicalTrials.gov Identifier: | NCT02525458 |
Other Study ID Numbers: |
QAMS-2015 |
First Posted: | August 17, 2015 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | August 2016 |
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