Evidence map›Paper›PMID 30365198›Full record

Trial reportJournal of prosthodontics : official journal of the American College of Prosthodontists2019

Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe.

Alyson Axe, Gary R Burnett, Kimberly R Milleman, Avinash Patil, Jeffery L Milleman

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of prosthodontics : official journal of the American College of Prosthodontists, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 87% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Denture cleanliness and hygiene: an overview.British dental journal · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 3 countries.

Alyson AxeGSK Consumer Healthcare, Weybridge, Surrey, UK.
Gary R BurnettGSK Consumer Healthcare, Weybridge, Surrey, UK.
Kimberly R MillemanSalus Research Inc., Fort Wayne, IN.
Avinash PatilSyneos Health, Pune, India.
Jeffery L MillemanSalus Research Inc., Fort Wayne, IN.
Procter & Gamble (United Kingdom) · GBSalus (United States) · USSyneos Health (India) · IN

Funding

GSK
6 · The paper itself

Abstract

purposeTo evaluate oral and dermal tolerance following use and user acceptability of an experimental denture-cleansing wipe. An exploratory objective was to develop a method to assess denture wipe effectiveness in removing debris from denture surfaces. MATERIALS AND

methodsThis was a single-center, randomized, controlled, parallel-group, examiner-blind study in participants with ≥1 full/partial denture. Participants were randomized to clean their dentures with the denture wipe (n = 76) or water (n = 76) up to 4 times per day for 14 days. Tolerability was assessed by treatment-emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment. Acceptability was assessed by questionnaire. The feasibility of a methodology to assess the efficacy of the wipe at removing food particles was also evaluated through determination of the mass of chewed peanut particles that the wipe removed after a single use (n = 31).

resultsThe proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]). There were no dermal TEAEs and no TEAE-related study withdrawals. Skin irritation scores with the denture wipe remained unchanged from baseline. Comparing before vs. after cleaning with the denture wipe, a higher proportion of participants rated their dentures as feeling extremely/very fresh (28.9% pre-/85.5% post-cleaning), feeling extremely/very clean (34.2%/86.8%) and looking extremely/very clean (43.5%/85.5%). More denture-wipe group participants than water-rinse group participants were extremely/very satisfied with the amount of debris removed from their dentures (88.1% vs 72.4%). The methodology used to assess the weight of peanut particles captured from the wipes/dentures appeared to be a feasible investigation technique.

conclusionsThe denture wipe was generally well-tolerated and had good user acceptability. The methodology for assessing the mass of peanut particles removed by denture wipes was successful.

Indexed as

Denture CleansersFemaleHumansMaleMiddle AgedOral HygieneSurveys and QuestionnairesTreatment OutcomeDenture CleansersDenture hygienesafety

Identifiers

PMID30365198
PMCPMC7328799
OpenAlexW2898269428

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.