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Frequency of Denture Cleanser Use and Denture Cleanliness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780661
First Posted: May 23, 2016
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This method development study will be a two treatment arm, randomized, cross over study in a population with edentulous upper arch restored with a maxillary complete denture. The lower may be a partial or full edentulous mandibular arch that may be restored with a stable complete, partial or implant supported denture.

Condition Intervention
Denture Cleansers Device: Denture Cleanser Daily Use Period Device: Denture Cleanser Weekly Use Period Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in Microbial count on Day 7 [ Time Frame: Baseline, Day 7 ]
    Microbial count will be measured by microbiological disc sampling. Pre-treatment samples will be taken from the left rough and left smooth denture surface. Post-treatment samples will be taken from the right rough and right smooth denture surface at Day 7.


Secondary Outcome Measures:
  • Change from baseline in Microbial count on Day 3 [ Time Frame: Baseline, Day 3 ]
    Microbial count will be measured by microbiological disc sampling. Pre-treatment samples will be taken from the left rough and left smooth denture surface. Post-treatment samples will be taken from the right rough and right smooth denture surface at Day 3.


Enrollment: 19
Actual Study Start Date: June 20, 2016
Study Completion Date: November 15, 2016
Primary Completion Date: September 1, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denture Cleanser Daily Use Period
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
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.
Other Name: Corega tablet
Other: Water
A cup of very warm water will be used to soak one denture cleansing tablet and dentures for per day (Day 0 to Day 7) or weekly (Day 0 and Day 7) treatment regimen.
Experimental: Denture Cleanser Weekly Use Period
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
One denture cleansing tablet will be soaked 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.
Other Name: Corega tablet
Other: Water
A cup of very warm water will be used to soak one denture cleansing tablet and dentures for per day (Day 0 to Day 7) or weekly (Day 0 and Day 7) treatment regimen.

Detailed Description:
This is a single-center, 2 treatment periods, examiner-blind, randomized, 7 day crossover study in adult participants with a complete maxillary denture. This is a method development study to investigate the changes in the level of denture plaque, microbial counts, microbial composition and stain on the maxillary dentures after daily denture cleanser use versus dentures that are cleaned weekly.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02780661


Locations
United Kingdom
GSK Investigational Site
Glasgow, United Kingdom, G2 3JZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02780661     History of Changes
Other Study ID Numbers: 205202
First Submitted: May 19, 2016
First Posted: May 23, 2016
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pharmaceutical Solutions