Evidence map›Paper›PMID 28353023›Full record

Trial reportClinical oral investigations2018

Efficacy of GUM® Hydral versus Biotène® Oralbalance mouthwashes plus gels on symptoms of medication-induced xerostomia: a randomized, double-blind, crossover study.

Anna Greta Barbe, Yasmin Schmidt-Park, Stefanie Hamacher, Sonja Henny Maria Derman, Michael Johannes Noack

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical oral investigations, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. 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 1 institution in 1 country.

Anna Greta BarbeCentre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany. anna.barbe@uk-koeln.de.
Yasmin Schmidt-ParkCentre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.
Stefanie HamacherInstitute of Medical Statistics, Informatics and Epidemiology, University of Cologne, 50924, Köln, Germany.
Sonja Henny Maria DermanCentre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.
Michael Johannes NoackCentre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Kerpener Str. 32, 50931, Köln, Germany.
University of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe objective of this study is to determine the efficacy of GUM® Hydral versus Biotène® Oralbalance (both a mouthwash plus gel) on the subjective burden and clinical symptoms of patients with medication-induced xerostomia. MATERIALS AND

methodsSubjects (N = 40) with medication-induced xerostomia (minimum 4/10 mm visual analog scale [VAS]) were randomized to treatment with GUM Hydral or Biotène Oralbalance mouthwash, both with gel, for 28 days. Subjects then entered a 21-day wash-out period, before crossing over to the other treatment for 28 days. Outcomes measured included the VAS, German Oral Health Impact Profile (OHIPG)-14, Xerostomia Questionnaire (XQ), after-use questionnaire, and clinical parameters.

resultsBoth GUM Hydral and Biotène Oralbalance significantly (p < 0.05) reduced VAS, OHIPG-14 total score and single items, and XQ Part 1 (oral dryness, oral pain, taste loss) and Part 2 items. GUM Hydral also significantly reduced the XQ Part 1 dysphagia score, while Biotène Oralbalance significantly reduced the halitosis organoleptic score and plaque index. Significant increases in saliva secretion did not reach clinical relevance. No significant between-group differences were observed, apart from OHIPG-14 items "trouble pronouncing words" and "uncertainty" in favor of GUM Hydral. No adverse effects were reported.

conclusionsBoth products effectively improve oral health and xerostomia-related quality of life. However, they cannot completely substitute the continuous in-mouth secretion of saliva, and symptomatic relief is temporary. Product selection will be based on personal preference. CLINICAL RELEVANCE: Both products diminish xerostomic burden and should be part of the management strategy. Affected patients should be informed of these treatments, since no adverse effects were reported.

Indexed as

Administration, OralCross-Over StudiesDouble-Blind MethodDrug CombinationsFemaleGelsGlucose OxidaseHumansLactoperoxidaseMaleMiddle AgedMouthwashesMuramidaseQuality of LifeSurveys and QuestionnairesXerostomiaBioteneDrug CombinationsGelsGlucose OxidaseLactoperoxidaseMouthwashesMuramidaseGelMedication-induced xerostomiaMouthwashOral health-related quality of lifeXerostomia questionnaireXerostomic burden

Identifiers

PMID28353023
OpenAlexW2603364015

What OpenQuestion holds

Textmetadata
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.