Microbial Evaluation of Denture Cleaning and Overnight Storage

NCT02454413 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical guidelines for denture care are available, but evidence for optimal nocturnal storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients. It is hypothetised that mechanical denture cleaning will decrease the impact of overnight denture storage condition on biofilm formation on acrylic removable dentures.

Conditions

Denture Hygiene

Keywords

dentures hygiene; biofilm formation; oral health

Outcome Measures

Primary Outcomes (1)

• Biofilm (quantity and quality) on the removable acrylic denture

  sample taken at day 5 of the test period

Secondary Outcomes (1)

• Oral health status

  oral health control at day 5 of the test period

Study Arms (4)

brush + water

SHAM COMPARATOR

denture brushing with water and soap + overnight storage in water

Other: denture brushing with water and soap

brush + cleansing tablet

ACTIVE COMPARATOR

denture brushing with water and soap + overnight storage in water with a cleansing tablet

Other: denture brushing with water and soap; Other: cleansing tablet

ultrasonic cleaning + water

SHAM COMPARATOR

ultrasonic denture cleaning + overnight storage in water

Other: ultrasonic denture cleaning

ultrasonic cleaning + cleansing tablet

ACTIVE COMPARATOR

ultrasonic denture cleaning + overnight storage in water with a cleansing tablet

Other: ultrasonic denture cleaning; Other: cleansing tablet

Interventions

denture brushing with water and soap OTHER

denture brushing with water and soap

brush + cleansing tablet; brush + water

ultrasonic denture cleaning OTHER

ultrasonic denture cleaning

ultrasonic cleaning + cleansing tablet; ultrasonic cleaning + water

cleansing tablet OTHER

addition of a cleansing tablet to the water in which the dentures are stored overnight

brush + cleansing tablet; ultrasonic cleaning + cleansing tablet

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Institutionalised frail elder
• Fully edentulous in lower and upper jaw
• Removable denture wearer in lower and upper jaw
• Good oral health

You may not qualify if:

• Current or history of corticosteroid treatment within the 3 months prior to the study
• Current or history of antimicrobial treatment within the 3 months prior to the study
• Inability to provide informed consent
• Inability to comply with the study requirements

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (23)

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  PMID: 3166009 BACKGROUND

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  PMID: 1945487 BACKGROUND

• Campos MS, Marchini L, Bernardes LA, Paulino LC, Nobrega FG. Biofilm microbial communities of denture stomatitis. Oral Microbiol Immunol. 2008 Oct;23(5):419-24. doi: 10.1111/j.1399-302X.2008.00445.x.

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• Sachdeo A, Haffajee AD, Socransky SS. Biofilms in the edentulous oral cavity. J Prosthodont. 2008 Jul;17(5):348-56. doi: 10.1111/j.1532-849X.2008.00301.x.

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  PMID: 20552089 BACKGROUND

• Teles FR, Teles RP, Sachdeo A, Uzel NG, Song XQ, Torresyap G, Singh M, Papas A, Haffajee AD, Socransky SS. Comparison of microbial changes in early redeveloping biofilms on natural teeth and dentures. J Periodontol. 2012 Sep;83(9):1139-48. doi: 10.1902/jop.2012.110506. Epub 2012 Mar 23.

  PMID: 22443543 BACKGROUND

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  PMID: 11896849 BACKGROUND

• Felton D, Cooper L, Duqum I, Minsley G, Guckes A, Haug S, Meredith P, Solie C, Avery D, Deal Chandler N; American College of Prosthodontists. Evidence-based guidelines for the care and maintenance of complete dentures: a publication of the American College of Prosthodontists. J Prosthodont. 2011 Feb;20 Suppl 1:S1-S12. doi: 10.1111/j.1532-849X.2010.00683.x.

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• Augsburger RH, Elahi JM. Evaluation of seven proprietary denture cleansers. J Prosthet Dent. 1982 Apr;47(4):356-9. doi: 10.1016/s0022-3913(82)80079-6. No abstract available.

  PMID: 6951034 BACKGROUND

• Duyck J, Vandamme K, Krausch-Hofmann S, Boon L, De Keersmaecker K, Jalon E, Teughels W. Impact of Denture Cleaning Method and Overnight Storage Condition on Denture Biofilm Mass and Composition: A Cross-Over Randomized Clinical Trial. PLoS One. 2016 Jan 5;11(1):e0145837. doi: 10.1371/journal.pone.0145837. eCollection 2016.

  PMID: 26730967 DERIVED

MeSH Terms

Interventions

Water; Soaps

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Joke JA Duyck, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: May 27, 2015
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 27, 2015

Record last verified: 2015-05