Condition category
Oral Health
Date applied
24/02/2020
Date assigned
27/02/2020
Last edited
27/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dario Di Nardo

ORCID ID

https://orcid.org/0000-0002-5054-0828

Contact details

Department of Oral and Maxillo Facial Sciences
Sapienza University of Rome
Via Caserta
6
Rome
00161
Italy
+39 (0)3393935527
dario.dinardo@uniroma1.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

4790

Study information

Scientific title

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

Acronym

Study hypothesis

Probiotic Streptococcus salivarius can reduce denture stomatitis.

Ethics approval

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

Study design

Single-centre interventional randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

15/01/2017

Overall trial end date

30/12/2019

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

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

Trial participating centre

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

Sponsor information

Organisation

Pharmextracta SpA

Sponsor details

Via G. Natta
28
Pontenure (PC)
29010
Italy
+39 (0)523510848
m.speroni@pharmextracta.com

Sponsor type

Industry

Website

http://www.pharmextracta.com

Funders

Funder type

Industry

Funder name

Pharmextracta SpA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication as an original article In an open access international medical journal as soon as possible.

IPD sharing statement
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).

Intention to publish date

30/03/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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