Frequency of Denture Cleanser Use and Denture Cleanliness

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Denture Cleansers

Treatments: Other: Water; Device: Denture Cleanser Weekly Use Period; Device: Denture Cleanser Daily Use Period

Study type: Interventional

Funder types: Industry

Identifiers

NCT02780661

205202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Denture Cleanser Daily Use Period

Experimental group

Description:

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.

Treatment:

Device: Denture Cleanser Daily Use Period

Other: Water

Denture Cleanser Weekly Use Period

Experimental group

Description:

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.

Treatment:

Device: Denture Cleanser Weekly Use Period

Other: Water