Clinical trial NCT02780661: Frequency of Denture Cleanser Use and Denture Cleanliness
Official title: A Method Development Clinical Study to Investigate the Efficacy of the Different Frequencies of Use of a Denture Cleanser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture Cleansers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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.

Primary outcomes:
measure: Change From Baseline in Aerobic Bacteria Microbial Count on Day 7
timeFrame: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
measure: Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7
timeFrame: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
measure: Change From Baseline in Candidal Microbial Count on Day 7
timeFrame: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)
Secondary outcomes:
measure: Change From Baseline in Aerobic Bacteria Microbial Count on Day 3
timeFrame: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)
measure: Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3
timeFrame: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)
measure: Change From Baseline in Candidal Microbial Count on Day 3
timeFrame: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.