Probiotic Streptococcus salivarius to reduce symptoms of denture stomatitis and oral colonization caused by Candida albicans

ISRCTN	ISRCTN14751782
DOI	https://doi.org/10.1186/ISRCTN14751782
Secondary identifying numbers	4790

Submission date: 24/02/2020
Registration date: 27/02/2020
Last edited: 27/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Denture stomatitis (DS) is characterized by soreness, pain, discomfort, and denture mobilization, and is the cause of multiple visits to the dental office. DS may also increase the risk of pulmonary (lung) and other systemic infections, particularly in institutionalized elderly subjects. The aim of this study is to evaluate the effects of a probiotic preparation, containing Streptococcus salivarius strain BLIS®K12, in Candida albicans positive patients affected by DS, and the duration of these effects.

Who can participate?
Patients of both sexes and all ages with one or both completely edentulous arches, affected by denture stomatitis

What does the study involve?
All patients are instructed to perform scrupulous mechanic denture and oral hygiene daily, to refrain from 24 hours wearing of the denture, and invited not to use oral rinses containing antimicrobial substances. Patients randomly allocated to the experimental group (EXP) are then invited to perform mechanic denture and oral hygiene as previously explained, and to take for 30 days one tablet of Bactoblis® in the evening, just before going to sleep, allowing the tablet to dissolve in the mouth, and to refrain from drinking for the next 60 minutes. Patients randomly allocated to the control group are invited to perform mechanic denture and oral hygiene as previously explained for 30 days.

What are the possible benefits and risks of participating?
Possible benefits are healing from denture stomatitis and improved quality of life. Risks are that the denture stomatitis persists without differences with the control group. No risks have been reported concerning the administration of probiotic Streptoccoccus salivarius.

Where is the study run from?
Sapienza University of Rome (Italy)

When is the study starting and how long is it expected to run for?
January 2017 to December 2019

Who is funding the study?
Pharmextracta SpA (Italy)

Who is the main contact?
Dr Maurizio Speroni
m.speroni@pharmextracta.com

Contact information

Dr Dario Di Nardo
Scientific

Department of Oral and Maxillo Facial Sciences, Sapienza University of Rome
Via Caserta, 6
Rome
00161
Italy

ORCID ID	0000-0002-5054-0828
Phone	+39 (0)3393935527
Email	dario.dinardo@uniroma1.it

Study information

Study design	Single-centre interventional randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Probiotic Streptococcus salivarius to reduce symptoms of denture stomatitis and oral colonization caused by Candida albicans
Study hypothesis	Probiotic Streptococcus salivarius can reduce denture stomatitis.
Ethics approval(s)	Approved 22/11/2017, Ethical committee of the Sapienza University of Rome Viale del Policinico (155 - 00161 Rome, Italy; +39 (0)649979822; comitato.etico@policlinicoumberto1.it), ref: 4790 Protocol n. 112/17
Condition	Denture stomatitis caused by Candida albicans
Intervention	Fifty adult denture wearers affected by denture stomatitis were enrolled and randomly divided into two groups: the experimental group was instructed to perform careful oral and denture hygiene and to use the probiotic Streptococcus salivarius mouth rinse for 30 days (Bactoblis® (Pharmaextracta Spa, Pontenure, Piacenza, Italy), containing 10(9) cfu of the probiotic strain Streptococcus salivarius BLIS®K12); the control group received only conventional hygiene instructions to clean dentures. Patients were evaluated for signs of DS at the beginning, the end and 30 days after the treatment. Microbiological samples were obtained at the beginning of the study and at the end of treatment to enumerate Candida albicans cells.
Intervention type	Supplement
Primary outcome measure	1. Presence/absence of subjective pain in the oral mucosae assessed by asking patients at 30 and 60 days 2. Presence/absence of sensation of dryness of the mouth assessed by asking patients at 30 and 60 days 3. Visual signs of denture stomatitis assessed by clinical observation made by clinician using Newton's classification at 30 and 60 days
Secondary outcome measures	1. Number of Candida albicans (cfu/ml) measured from a specimen obtained by streaking a cotton swab along the gingiva, at 0 and 30 days 2. Number of Candida albicans (cfu/ml) measured from a specimen of saliva at 0 and 30 days
Overall study start date	15/01/2017
Overall study end date	30/12/2019

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	50
Participant inclusion criteria	1. At least one totally edentulous dental arch 2. A full arch well-fitting removable acrylic denture 3. Subjective discomfort/pain in relation to denture 4. Clinical signs of denture stomatitis
Participant exclusion criteria	1. Use of adhesives for denture stabilization 2. Assumption of antibiotics in the last 30 days 3. Systemic diseases influencing homeostasis of the oral mucosae
Recruitment start date	01/01/2019
Recruitment end date	28/02/2019

Locations

Countries of recruitment

Italy

Study participating centre

Sapienza University of Rome

Department of oral and maxillofacial sciences
Via Caserta, 6
Rome
00161
Italy

Sponsor information

Pharmextracta SpA
Industry

Via G. Natta, 28
Pontenure (PC)
29010
Italy

Phone	+39 (0)523510848
Email	m.speroni@pharmextracta.com
Website	http://www.pharmextracta.com

Funders

Funder type

Industry

Pharmextracta SpA

No information available

Results and Publications

Intention to publish date	30/03/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publication as an original article In an open access international medical journal as soon as possible.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Claudio Passariello (claudio.passariello@uniroma1.it).

Editorial Notes

25/02/2020: Trial's existence confirmed by Ethical committee of the Sapienza University of Rome Viale del Policinico.