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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 4790 |
| Sponsor | Pharmextracta SpA |
| Funder | Pharmextracta SpA |
- 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
Plain English summary of protocol
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
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 |
| dario.dinardo@uniroma1.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Probiotic Streptococcus salivarius to reduce symptoms of denture stomatitis and oral colonization caused by Candida albicans |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Presence/absence of subjective pain in the oral mucosae assessed by asking patients at 30 and 60 days |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Caserta, 6
Rome
00161
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/02/2020: Trial's existence confirmed by Ethical committee of the Sapienza University of Rome Viale del Policinico.
