Probiotics for gum health during treatment with braces

ISRCTN ISRCTN95085398
DOI https://doi.org/10.1186/ISRCTN95085398
Secondary identifying numbers MBRU-IRB-2018-015
Submission date
04/09/2018
Registration date
01/04/2019
Last edited
07/04/2020
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 of protocol

Background and study aims
The use of orthodontic appliances (braces) increases biofilm (bacteria) retention and may lead to periodontal (gum) deterioration. Probiotics have been suggested to be beneficial in preventing or treating gingival (gum) inflammation. The aim of this study is to assess the inflammatory changes in the periodontium (gums) of orthodontic patients taking probiotics compared to usual oral hygiene. Secondary aims include assessing plaque, side effects, patient-reported outcomes and salivary microbiome (bacteria).

Who can participate?
Orthodontic patients aged under 18

What does the study involve?
Participants are randomly allocated to one of two groups. Group 1 consume probiotic tablets together with regular oral hygiene, while individuals in Group 2 do not receive the probiotic supplements. Assessments take place at the start of the study and after 3 months, assessing plaque, gingivitis (gum inflammation), gingival bleeding, potential side effects and patient-reported outcomes. Saliva samples are collected for salivary microbiome tests.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Mohammed Bin Rashid University of Medicine and Health Sciences (United Arab Emirates)

When is the study starting and how long is it expected to run for?
February 2018 to December 2020

Who is funding the study?
Mohammed Bin Rashid University of Medicine and Health Sciences (United Arab Emirates)

Who is the main contact?
Dr Eleftherios Kaklamanos

Contact information

Dr Eleftherios Kaklamanos
Scientific

Mohammed Bin Rashid University of Medicine and Health Sciences
Building 14, Dubai Healthcare City
Dubai
P.O Box 505055
United Arab Emirates

ORCiD logoORCID ID 0000-0002-0513-5110

Study information

Study designSingle-center single-blind (to clinical and laboratory examiner) parallel-group randomized controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Other
Study typePrevention
Scientific titleA single-centre investigator-blinded randomized parallel-group study to investigate the effect of probiotic strains Streptococcus salivarius M18 and Lactobacillus acidophilus on gingival health of paediatric patients undergoing treatment with fixed orthodontic appliances
Study objectivesGingival bleeding on probing is less in orthodontic patients consuming probiotics in addition to regular oral hygiene, compared to patients practicing daily home oral hygiene alone.
Ethics approval(s)Mohammed Bin Rashid University of Medicine and Health Sciences Institutional Review Board
Date of approval: 04 June 2018
Reference number: MBRU-IRB-2018-015
Health condition(s) or problem(s) studiedGingivitis, malocclusion treatment
InterventionSubjects will be randomized into 2 groups with the aid of a computer program:
Intervention group: Probiotic tablet + Usual home oral hygiene [according to manufacturer instructions, the participants will chew two tablets once daily for 3 months]
No Intervention group: Usual home oral hygiene

Data recordings of all patients will take place at baseline and 3 months [end of study] by previously calibrated examiner blinded for the group assignment, assessing plaque, gingivitis, gingival bleeding, potential adverse effects and patient-reported outcomes. Moreover, at baseline and 3-month examinations [end of study], whole saliva samples will be collected for salivary microbiome determination.
Intervention typeSupplement
Primary outcome measureGingival bleeding on probing: percentage of the buccal mesial, midline and distal sites from second premolar to second premolar which bleed upon probing, using the criteria for bleeding of the Gingival Index (Löe and Silness, 1963) at baseline and 3 months
Secondary outcome measuresMeasured at baseline and 3 months:
1. Gingival Index assessed on the buccal surfaces from second premolar to second premolar (Löe and Silness, 1963)
2. Plaque Index modified (Clerehugh et al., 1998)
3. Potential adverse effects: inspection of the hard and soft oral cavity tissues and self-reported
4. Patient-reported outcomes (adapted from Herrera et al., 2017)
Overall study start date01/02/2018
Completion date31/12/2020

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexBoth
Target number of participants50 (allowing for dropouts)
Key inclusion criteria1. Healthy individuals, aged under 18 years, planned for simultaneous full arch upper and lower fixed labial orthodontic appliance therapy from second premolar to second premolar
2. In good general health
3. Have a dental history that includes brushing at least once a day
4. Willing and able to comply with the trial regime
5. Normal anatomical periodontal attachment
6. Gingival bleeding on probing on at least 30% of the buccal mesial, midline and distal sites of the teeth examined using the criteria for bleeding of the Gingival Index (Löe and Silness, 1963).
Key exclusion criteria1. Inability to make informed consent
2. Allergies, sensitivities or food intolerance
3. Presence of any congenital syndromes of the head and neck
4. Medical contraindications such as heart condition, immucompromised state or diseases necessitating antibiotic cover prior to procedures, use of immunosuppressants,
5. History of surgery within the past year or planned within the next 90 days
6. Severe nausea, fever, vomiting, bloody diarrhea or severe abdominal pain within the past one month
7. Presence of special physical or mental needs that would compromise manual dexterity
8. Chronic use of medications of any kind, probiotics or food supplements of any kind
9. Use of antibiotics, anti-inflammatory, steroids or hormones within one month from the start of the study.
10. Oral prophylaxis within one month from the start of the study.
11. Use of antibacterial mouthrinses or toothpastes with supplementary antibacterial agents.
12. Poor compliance with oral hygiene regimens
13. Poor periodontal health such as presence of supragingival calculus, subgingival calculus or periodontal pocketing
14. Extensive dental restorations or uncontrolled caries activity
15. Pregnancy, smokers
16. Planned use of premolar bands
Date of first enrolment15/09/2019
Date of final enrolment30/03/2020

Locations

Countries of recruitment

  • United Arab Emirates

Study participating centre

Mohammed Bin Rashid University of Medicine and Health Sciences
Building 14, Dubai Healthcare City
PO Box 505055
Dubai
PO Box 505055
United Arab Emirates

Sponsor information

Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences
University/education

Building 34, Dubai Healthcare City
Dubai
PO Box 505055
United Arab Emirates

Website https://www.mbruniversity.ac.ae
ROR logo "ROR" https://ror.org/05g48k331

Funders

Funder type

University/education

Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences

No information available

Results and Publications

Intention to publish date31/07/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planAdditional study documents will be available upon request. Presentations in congresses and publication in peer-reviewed articles.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 08/09/2019 01/11/2019 Yes No

Editorial Notes

07/04/2020: The following changes have been made:
1. The overall trial end date has been changed from 31/03/2020 to 31/12/2020.
2. The intention to publish date has been changed from 30/09/2020 to 31/07/2021.
3. The plain English summary has been updated to reflect the changes above.
01/11/2019: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2019 to 15/09/2019.
2. Publication reference added.