Frequency of Denture Cleanser Use and Denture Cleanliness | NCT02780661

NCT02780661

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Denture Cleanser Daily Use Period	Experimental	Participants will be instructed to soak upper arch dentures in the evening in cup of very warm water (150 millilitre [ml]) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (mins). Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds. Cleaning of upper arch dentures in the morning is not permitted. Lower arch dentures will be cleaned using the participant's normal oral hygiene procedures in the morning and evening. If the participants will have lower removable partial or complete dentures, the soaking of these dentures will be done in a separate cup from the cup provided for soaking the upper denture.	Device: Denture Cleanser Daily Use Period Other: Water
Denture Cleanser Weekly Use Period	Experimental	Participants will be instructed to soak upper arch dentures in the evening in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds. Cleaning of upper arch dentures in the morning is not permitted. Lower arch dentures will be cleaned using the participant's normal oral hygiene procedures in the morning and evening. If the participants will have lower removable partial or complete dentures, the soaking of these dentures will be done in a separate cup from the cup provided for soaking the upper denture.	Device: Denture Cleanser Weekly Use Period Other: Water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Denture Cleanser Daily Use Period	Device	One denture cleansing tablet will be soaked in a cup of very warm water (150 ml) with dentures for Day 0 to Day 7 for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Aerobic Bacteria Microbial Count on Day 7	Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10-millimeter (mm) filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.	Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7	Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.	Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Change From Baseline in Candidal Microbial Count on Day 7	Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Aerobic Bacteria Microbial Count on Day 3	Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18 and 84 years inclusive.
Good general and mental health with, in the opinion of the Investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination; Absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
Maxillary Arch: Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture.
Mandibular Arch: Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. (Mandibular dentures are not used for assessments or measures).
Maxillary dentures must be considered to be moderately well-fitting at the screening visit. (Kapur Index, Olshan Modification: retention score >2, stability score >2).
Maxillary dentures must be considered to be well-made based on design and construction criteria specified in the protocol.

Exclusion Criteria:

Women who are breast-feeding, are known to be pregnant or who are intending to become pregnant over the duration of the study.
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Previous participation in this study or in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
Recent history (within the last year) of alcohol or other substance abuse.
Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.
Implanted with a cardiac pacemaker.
Daily doses of medication (example Antibiotics, Inhaled steroids etc.) that might interfere with ability to perform the study according to protocol or might affect the efficacy assessments (as determined by the Investigator/ Examiner).
Any clinically significant or relevant oral abnormality that, in the opinion of the Investigator, could affect the participant's participation in the study.
Any pre-existing oral irritations.
Any recent (within 30 days) gingival /oral surgery.
Participants who are unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of the study.
An employee of the sponsor or the study site or members of their immediate family.
An employee of any toothpaste manufacturer or their immediate family.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director
GSK Clinical Trials	GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Glasgow		G2 3JZ	United Kingdom

PubMed Identifier	Type	Citation	Retractions
30598732	Derived	Ramage G, O'Donnell L, Sherry L, Culshaw S, Bagg J, Czesnikiewicz-Guzik M, Brown C, McKenzie D, Cross L, MacInnes A, Bradshaw D, Varghese R, Gomez Pereira P, Jose A, Sanyal S, Robertson D. Impact of frequency of denture cleaning on microbial and clinical parameters - a bench to chairside approach. J Oral Microbiol. 2018 Oct 29;11(1):1538437. doi: 10.1080/20002297.2018.1538437. eCollection 2019.

Label	URL
Related Info	View source

Arm/Group Information

ID	Title	Description
FG000	Denture Cleanser Tablet: Daily Use /Weekly Use	Participants were instructed to soak upper arch dentures in cup of very warm water (150 milliliter [mL]) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (min.) (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days) in treatment period 1. Following 7 day wash out period, same participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days); and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins in treatment period 2. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
FG001	Denture Cleanser Tablet: Weekly Use/ Daily Use	Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins in treatment period 1. Following 7 day wash out period, same participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (min.) (supervised product use at site: Day 0,3,7; home use of product in evening for rest of the days) in treatment period 1. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.

ID	Title	Description
BG000	All Randomized Participants	All randomized participants were included for baseline evaluation.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Change From Baseline in Aerobic Bacteria Microbial Count on Day 7	Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10-millimeter (mm) filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.	Analysis for this outcome was performed on intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of microbial count from disc sampling.	Posted		Mean	Standard Deviation	log10(CFU[colony forming unit]/disc+1)		Baseline (Day 0 pre-treatment), Day 7 (post-treatment)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Denture Cleanser Tablet: Daily Use	Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders		Systematic Assessment

Title	Organization	Phone	Extension	Email
GSK Response Center	GlaxoSmithKline	866-435-7343		GSKClinicalSupportHD@gsk.com

ID	Term
D014867	Water

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

ID	Title	Description
OG000	Denture Cleanser Tablet: Daily Use Period	Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.
OG001	Denture Cleanser Tablet: Weekly Use	Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning & evening.