Last updated: 11/19/2018 15:40:15
Frequency of denture cleanser use and denture cleanliness
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in aerobic bacteria microbial count on Day 7
Timeframe: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Change from baseline in anaerobic bacteria microbial count on Day 7
Timeframe: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Change from baseline in candidal microbial count on Day 7
Timeframe: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Secondary outcomes:
Change from baseline in aerobic bacteria microbial count on Day 3
Timeframe: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)
Change from baseline in anaerobic bacteria microbial count on Day 3
Timeframe: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)
Change from baseline in candidal microbial count on Day 3
Timeframe: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)
Interventions:
Device: Denture Cleanser Daily Use Period
Device: Denture Cleanser Weekly Use Period
Other: Water
Enrollment:
19
Observational study model:
Not applicable
Primary completion date:
2016-15-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Denture Cleansers
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2016 to November 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 84 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-15-11
Actual study completion date
2016-15-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Access to clinical trial data by researchers
Visit website