Denture CleansersNCT03478644
Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe
A study testing Experimental Denture Wipe and Tap Water in people with Denture Cleansers, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Cleansers
- What is being tested?
- Experimental Denture Wipe and Tap Water
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2016to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrated understanding of the study procedures, restrictions and was willing to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the informed consent form.
- Understood and was willing, able and comply with all study procedures and restrictions.
- Participant was in good general and mental health with, in the opinion of the investigator or medically qualified designee - (a) no clinically significant and relevant abnormalities of medical or physical history; (b) absence of any condition that impacted on the participant's safety or well-being or affected the individual's ability to understand and follow study procedures.
- Denture Requirements, fully or partially edentulous: (a) Phase 1 eligible participants had a full upper denture and may Have a full or partial lower denture or no lower Denture; (b) Phase 2 eligible subjects will have at least one full or partial denture; (c) Dentures considered in good condition according to the investigator or dental examiner, with no damage according to assessment criteria; (d) Participants with a peanut particle migration rating greater than zero on the upper denture only for participants screened for food removal testing.
- Skin Phototype (Fitzpatrick), I to IV, according to the scale only skin phototypes I to IV are acceptable for inclusion in this study: Type I - White; very fair; freckles; typical albino skin. Always burns, never tans, Type II -White; fair. Usually burns, tans with difficulty, Type III - Beige; very common. Sometimes mild burn, gradually tans to a light brown, Type IV - Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease to a moderate brown, Type V - Dark brown. Very rarely burns, tans very easily, Type VI Black - Never burns, tans very easily, deeply pigmented.
Who cannot join
- Women who were known to be pregnant or who were intending to become pregnant over the duration of the study.
- Women who were breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Known allergy to any nuts or peanuts. History of allergic reactions or intense feelings of discomfort to topically used products: cosmetics or drugs.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, except for participants who were enrolled on GSKCH study 205915 who might enrolled onto this study 7 days after their completion of 205915. Previous participation in this study.
- Recent history (within the last one year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
Show all 9Show fewer
- Denture adhesive users were excluded from this study.
- Participants with OST findings such as, stomatitis, open sores, lesions, redness or swelling were excluded.
- Other Conditions because of participants were excluded are as follows: History of swallowing or choking difficulties; participants unwilling to refrain from using their existing denture cleansing routine for the duration of the study; taking or have taken a bisphosphonate drug for treatment of osteoporosis; skin marks in the experimental area which may interfere with the evaluation of potential skin reactions; active skin diseases (local and/or disseminated) that may interfere with the study results; participants with immunodeficiencies, intense sunlight exposure or tanning session within 15 days before the baseline evaluation or during the study that has resulted in sunburn; body cosmetic and/or dermatological treatment until three weeks before screening or during the study; continual use of therapeutic, topical or systemic use of the following drugs: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs and corticosteroids within two weeks before the screening for chronic conditions; oral or topical treatment with vitamin A acid and/or its derivatives within one month before start of study; vaccination within three weeks before or during the study; participants with dermographism; any condition not previously mentioned that in the investigator's opinion may impair the study evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study To Determine The Oral and Dermal Tolerability of an Experimental Denture Wipe
The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the denture wipe at removing food debris as exploratory objective.
Read the detailed description
This was a two phase single-center study. Phase 1 (Food removal testing), was monadic and only the wipe treatment was administered to complete upper dentures. Phase 1 participants then progressed to phase 2 (oral soft tissue [OST] and dermal assessment) which was an examiner blind parallel group, randomized and stratified (by denture type) design where both treatments (a single wipe and water control) were administered. Phase 2 participants included both fully and partially edentulous adult participants. Participants were not permitted to use any denture cleansers other than those provided and were not permitted to use denture fixatives for the duration of the study. The study comprised a Screening/Baseline visit and a 2 week Treatment Period with visits after 1 and 2 weeks use. Following screening participants who were eligible for Phase 1 were assessed for food migration adequacy. Participants consumed 30-32g (gram) of non-salted peanut halves in a controlled manner, then briefly rinsed their mouth with water and removed their upper denture. The investigator visually assessed the peanut particle migration underneath the denture on a 0-3 scale and those participants with a score greater than 0 were wiped by the participant with the experimental denture wipe. The mass of peanuts removed by the wipe and those remaining on the denture was subsequently measured. For a subset of participants (2 participants per peanut particle migration scale score), their dentures were photographed after peanut consumption both before and after use of the experimental denture wipe. Phase 1 participants then continued into Phase 2. All Phase 2 participants undertook an OST examination and a dermatological assessment of both sides of their lead hand, then randomized. The dental examiner and dermatologist were blinded to the treatment allocation. The results of these assessments served as the baseline reading. Participants were then instructed on the use of their assigned treatment with the first application undertaken and supervised at the study site. Participants were provided with a diary card to record their treatment applications and a consumer acceptability questionnaire to be completed at the time of their first at home treatment use. Participants were also provided with denture cleansing tablets for use overnight for the duration of the study in order to maintain denture hygiene. Participants returned to the study site after 7±3 and 14±3 days use of product for repeat OST and dermatological assessments.
- Conditions
- Denture Cleansers
- Being tested
- Experimental Denture Wipe, Tap Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Denture WipeDevice
Participants were instructed to use the experimental wipe to clean their dentures, external to their mouth, up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days. Participants were instructed to use one wipe per denture.
Tap WaterOther
Participants were instructed to use running tap water to clean their dentures up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Denture Wipe | Experimental | Participants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily. Receives: Device: Experimental Denture Wipe |
| Tap Water | Placebo comparator | Participants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily. Receives: Other: Tap Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use
Proportion of participants experiencing or reporting TE oral AEs on or before 14 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).
Measured: up to 14 days
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use
Proportion of participants experiencing or reporting TE oral AEs on or before 7 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).
Measured: up to 7 days
Secondary outcomes (2)
Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use
Dermal assessment performed by a suitably qualified dermatologist on the front and back of the participant's dominant hand (hand with which participant used to hold the wipe during use) using skin irritation score that range from 0-4 as follows: 0 = no apparent cutaneous involvement, 0.5= equivocal reaction, 1= slight erythema with or without oedema, 2= moderate erythema, oedema with or without papules, 3= severe erythema, oedema with or without papules, 4= severe erythema, oedema with vesicles or blisters. Any site where skin irritation was scored ≥2, was visually assessed and reported.
Measured: Day 7, Day 14
Number of Participants Responses for Consumer Acceptability Questionnaire Score
All the participants supplied with a consumer acceptability questionnaire (Question [Q] 1 to 4) to complete immediately before \& after their first use of treatment at home after eating a meal. The number of participants with individual score was reported. After eating \& before cleaning denture: Q1= how fresh does denture feel?, Q2= how clean does denture feel?; Look in the mirror and smile, now answer the following questions: Q3= after eating \& before cleaning, how clean does denture/smile look ?, Q4= after removing \& cleaning denture, how fresh does denture feel?, Q5= after removing \& cleaning denture, run your tongue over denture teeth, how clean does denture feel?, Q6= after removing \& cleaning denture, how clean does denture/smile look?, Q7= after removing \& cleaning denture, how satisfied are you with amount of debris removed? All questions were scored as follows for respective parameter(fresh/clean/satisfied): 0=Not at all, 1=slightly, 2=moderately, 3=very, 4=extremely.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start10 Oct 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Denture CleansersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478644
- Sponsor's protocol ID
- 203115
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2018
- Last updated
- 15 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study To Determine The Oral and Dermal Tolerability of an Experimental Denture Wipe
- ClinicalTrials.gov ID
- NCT03478644
- Acronym / sponsor ID
- 203115
- Conditions
- Denture Cleansers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the denture wipe at removing food debris as exploratory objective.
Detailed description
This was a two phase single-center study. Phase 1 (Food removal testing), was monadic and only the wipe treatment was administered to complete upper dentures. Phase 1 participants then progressed to phase 2 (oral soft tissue [OST] and dermal assessment) which was an examiner blind parallel group, randomized and stratified (by denture type) design where both treatments (a single wipe and water control) were administered. Phase 2 participants included both fully and partially edentulous adult participants. Participants were not permitted to use any denture cleansers other than those provided and were not permitted to use denture fixatives for the duration of the study. The study comprised a Screening/Baseline visit and a 2 week Treatment Period with visits after 1 and 2 weeks use. Following screening participants who were eligible for Phase 1 were assessed for food migration adequacy. Participants consumed 30-32g (gram) of non-salted peanut halves in a controlled manner, then briefly rinsed their mouth with water and removed their upper denture. The investigator visually assessed the peanut particle migration underneath the denture on a 0-3 scale and those participants with a score greater than 0 were wiped by the participant with the experimental denture wipe. The mass of peanuts removed by the wipe and those remaining on the denture was subsequently measured. For a subset of participants (2 participants per peanut particle migration scale score), their dentures were photographed after peanut consumption both before and after use of the experimental denture wipe. Phase 1 participants then continued into Phase 2. All Phase 2 participants undertook an OST examination and a dermatological assessment of both sides of their lead hand, then randomized. The dental examiner and dermatologist were blinded to the treatment allocation. The results of these assessments served as the baseline reading. Participants were then instructed on the use of their assigned treatment with the first application undertaken and supervised at the study site. Participants were provided with a diary card to record their treatment applications and a consumer acceptability questionnaire to be completed at the time of their first at home treatment use. Participants were also provided with denture cleansing tablets for use overnight for the duration of the study in order to maintain denture hygiene. Participants returned to the study site after 7±3 and 14±3 days use of product for repeat OST and dermatological assessments.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Denture Wipe | Experimental | Device: Experimental Denture WipeParticipants of this arm were instructed to use the experimental wipe to clean their dentures up to 4 times daily. |
| Tap Water | Placebo comparator | Other: Tap WaterParticipants of this arm were instructed to use running tap water to clean their dentures up to 4 times daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Demonstrated understanding of the study procedures, restrictions and was willing to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the informed consent form.
- Understood and was willing, able and comply with all study procedures and restrictions.
- Participant was in good general and mental health with, in the opinion of the investigator or medically qualified designee - (a) no clinically significant and relevant abnormalities of medical or physical history; (b) absence of any condition that impacted on the participant's safety or well-being or affected the individual's ability to understand and follow study procedures.
- Denture Requirements, fully or partially edentulous: (a) Phase 1 eligible participants had a full upper denture and may Have a full or partial lower denture or no lower Denture; (b) Phase 2 eligible subjects will have at least one full or partial denture; (c) Dentures considered in good condition according to the investigator or dental examiner, with no damage according to assessment criteria; (d) Participants with a peanut particle migration rating greater than zero on the upper denture only for participants screened for food removal testing.
- Skin Phototype (Fitzpatrick), I to IV, according to the scale only skin phototypes I to IV are acceptable for inclusion in this study: Type I - White; very fair; freckles; typical albino skin. Always burns, never tans, Type II -White; fair. Usually burns, tans with difficulty, Type III - Beige; very common. Sometimes mild burn, gradually tans to a light brown, Type IV - Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease to a moderate brown, Type V - Dark brown. Very rarely burns, tans very easily, Type VI Black - Never burns, tans very easily, deeply pigmented.
Key exclusion criteria (9 listed)
- Women who were known to be pregnant or who were intending to become pregnant over the duration of the study.
- Women who were breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Known allergy to any nuts or peanuts. History of allergic reactions or intense feelings of discomfort to topically used products: cosmetics or drugs.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, except for participants who were enrolled on GSKCH study 205915 who might enrolled onto this study 7 days after their completion of 205915. Previous participation in this study.
- Recent history (within the last one year) of alcohol or other substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Denture WipeParticipants were instructed to use the experimental wipe to clean their dentures, external to their mouth, up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days. Participants were instructed to use one wipe per denture. | Device | Experimental Denture Wipe |
| Tap WaterParticipants were instructed to use running tap water to clean their dentures up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days. | Other | Tap Water |
Primary outcome
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use
Time frame: up to 14 days
Proportion of participants experiencing or reporting TE oral AEs on or before 14 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use
Time frame: up to 7 days
Proportion of participants experiencing or reporting TE oral AEs on or before 7 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).
2 secondary outcomes
Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use
Time frame: Day 7, Day 14
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Denture Cleansers
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Denture Wipe and Tap Water in people with Denture Cleansers, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.