Evidence map›Paper›PMID 33711986›Full record

Trial reportBMC oral health2021

Effect of a newly developed pastille on the salivary flow rate in subjects with dry mouth symptoms: a randomized, controlled, monocentric clinical study.

S Bielfeldt, D Wilhelm, C Neumeister, U Schwantes, K-P Wilhelm

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC oral health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 25% 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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 2 institutions in 1 country.

S BielfeldtproDERM Institute for Applied Dermatological Research, Kiebitzweg 2, 22869, Schenefeld, Hamburg, Germany.
D WilhelmproDERM Institute for Applied Dermatological Research, Kiebitzweg 2, 22869, Schenefeld, Hamburg, Germany.
C NeumeisterDr. Pfleger Arzneimittel GmbH, Dr.-Robert-Pfleger-Str. 12, 96052, Bamberg, Germany. claudia.neumeister@dr-pfleger.de.ORCID 0000-0001-7976-5003
U SchwantesDr. Pfleger Arzneimittel GmbH, Dr.-Robert-Pfleger-Str. 12, 96052, Bamberg, Germany.
K-P WilhelmproDERM Institute for Applied Dermatological Research, Kiebitzweg 2, 22869, Schenefeld, Hamburg, Germany.
Dermatologikum Hamburg · DEDr. Pfleger Arzneimittel (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundXerostomia is associated with several diseases and is a side effect of certain drugs, resulting from reduced saliva secretion. Often, aged and sometimes younger people suffer from (idiopathic) xerostomia. Chewing gum and sucking pastilles may relieve symptoms of xerostomia by increasing the salivary flow rate due to the mechanical effect of sucking and gustatory stimulation. Swallowing problems and the urge to cough or experiencing a tickling sensation in the throat might be alleviated through a reduction in dry mouth symptoms. We investigated whether a pastille containing four polysaccharides increased the salivary flow rate and relieved the symptoms of dry mouth.

methodsParticipating subjects with xerostomia were randomized into two equally balanced treatment groups. Subjects received the pastille on Day 1 and a control product (Parafilm®) on Day 3, or vice versa. Unstimulated saliva was collected every 2.5 min for 0-10 min. Stimulated saliva was collected after subjects sucked the pastille or the control product. The salivary flow rate was determined gravimetrically, and, in parallel, the feeling of dry mouth was assessed using a visual analog scale. Saliva surface tension was measured in pooled saliva samples (0-5 min of sampling). Additionally, in stimulated saliva from six subjects who sucked the pastille, the presence of the main ingredient-gum arabic-was examined by Raman spectroscopy.

resultsChewing the pastille significantly increased the mean salivary flow rate by 8.03 g/10 min compared to the mean changes after chewing the control product (+ 3.71 g/10 min; p < 0.0001). The mean score of dry mouth was significantly alleviated by the pastille (- 19.9 ± 17.9 mm) compared to the control product (- 3.3 ± 18.1 mm). No difference between the two products was seen regarding the saliva surface tension. Gum arabic was present in the saliva of all investigated subjects for up to 10 min after sucking the pastille.

conclusionsThe pastille was well tolerated and effective in increasing the salivary flow rate and reducing mouth dryness after sucking. These results were in line with the detection of the main ingredient, gum arabic, in saliva for up to 10 min after sucking the pastille. Trial registration German Register Clinical Trials (Deutsches Register Klinische Studien, DRKS) DRKS-ID: DRKS00017393, Registered 29 May 2019, https://www.drks.de/drks_web/navigate.do?navigationId=trial . HTML&TRIAL_ID = DRKS00017393.

Indexed as

XerostomiaAgedChewing GumHumansSalivaSalivationSecretory RateChewing GumDry mouthMedical devicePastilleRaman spectroscopy of salivaSalivary flow rateSaliva surface tensionXerostomia

Identifiers

PMID33711986
PMCPMC7953607
OpenAlexW3134734230

What OpenQuestion holds

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LicenceCC BY
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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.