Evidence map›Paper›PMID 37179287›Full record

Trial reportBMC oral health2023

Trehalose versus carboxymethylcellulose oral spray for relieving radiation-induced xerostomia in head and neck cancer patients: a randomized controlled trial.

Pornpan Piboonratanakit, Joao N Ferreira, Kulpriya Pravinvongvuthi, Khwanchanok Maison, Ganokon Urkasemsin, Thirayu Boonroung, Anussara Prayongrat, Chawalit Lertbutsayanukul, Jeerus Sucharitakul, Anjalee Vacharaksa

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC oral health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 24% 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, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  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

10 authors at 3 institutions in 1 country.

Pornpan PiboonratanakitDepartment of Oral Medicine, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.
Joao N FerreiraAvatar Biotechnologies for Oral Health and Healthy Longevity Research Unit, Department of Research Affairs, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.
Kulpriya PravinvongvuthiGeriatric and Special Patients (International) Program, Faculty of Dentistry, Chulalongkorn University, 34 Henri-Dunant Road, Pathumwan, Bangkok, 10330, Thailand.
Khwanchanok MaisonAvatar Biotechnologies for Oral Health and Healthy Longevity Research Unit, Department of Research Affairs, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.
Ganokon UrkasemsinDepartment of Preclinic and Applied Animal Science, Faculty of Veterinary Science, Mahidol University, Bangkok, Thailand.
Thirayu BoonroungDental Department, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Anussara PrayongratDivision of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Chawalit LertbutsayanukulDivision of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Jeerus SucharitakulDepartment of Biochemistry, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.
Anjalee VacharaksaGeriatric and Special Patients (International) Program, Faculty of Dentistry, Chulalongkorn University, 34 Henri-Dunant Road, Pathumwan, Bangkok, 10330, Thailand. anjalee.v@chula.ac.th.
Chulalongkorn University · THKing Chulalongkorn Memorial Hospital · THMahidol University · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to investigate the effect of trehalose oral spray to relieve radiation-induced xerostomia on a randomized controlled trial (RCT).

methodsPrior to RCT, the effect of trehalose (5-20%) on the epithelial growth of fetal mouse salivary gland (SG) explants was evaluated to confirm if 10% trehalose exerted the best epithelial outcomes. Participants who completed radiotherapy for head and neck cancer (HNC) treatment were enrolled in a double-blind RCT, according to inclusion and exclusion criteria as per the CONSORT statement. The experimental group (n = 35) received 10% trehalose spray, while the control group (n = 35) received carboxymethylcellulose (CMC) spray to apply intra-orally 4 times/day for 14 days. Salivary pH and unstimulated salivary flow rate were recorded pre- and post-interventions. The Xerostomia-related Quality of Life scale (XeQoLs) was filled, and scores assessed post-interventions.

resultsIn the SG explant model, pro-acinar epithelial growth and mitosis was supported by 10% topical trehalose. As for RCT outcomes, salivary pH and unstimulated salivary flow rate were significantly improved after use of 10% trehalose spray when compared to CMC (p < 0.05). Participants reported an improvement of XeQoLs dimension scores after using trehalose or CMC oral sprays in terms of physical, pain/discomfort, and psychological dimensions (p < 0.05), but not social (p > 0.05). When comparing between CMC and trehalose sprays, XeQoLs total scores were not statistically different (p > 0.05).

conclusionsThe 10% trehalose spray improved salivary pH, unstimulated salivary flow rate, and the quality-of-life dimensions linked with physical, pain/discomfort, and psychological signs. The clinical efficacy of 10% trehalose spray was equivalent with CMC-based saliva substitutes for relieving radiation-induced xerostomia; therefore, trehalose may be suggested in alternative to CMC-based oral spray.(Thai Clinical Trials Registry; https://www.thaiclinicaltrials.org/ TCTR20190817004).

Indexed as

Carboxymethylcellulose SodiumHead and Neck NeoplasmsTrehaloseXerostomiaHumansOral SpraysCarboxymethylcellulose SodiumOral SpraysTrehaloseHead and neck cancerHyposalivationRadiotherapySalivary glandTrehaloseXerostomia

Identifiers

PMID37179287
PMCPMC10182540
OpenAlexW4376504039

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.