Condition category
Oral Health
Date applied
04/09/2018
Date assigned
01/04/2019
Last edited
01/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 March 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eleftherios Kaklamanos

ORCID ID

http://orcid.org/0000-0002-0513-5110

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MBRU-IRB-2018-015

Study information

Scientific title

A 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

Acronym

Study hypothesis

Gingival 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

Mohammed Bin Rashid University of Medicine and Health Sciences Institutional Review Board
Date of approval: 04 June 2018
Reference number: MBRU-IRB-2018-015

Study design

Single-center single-blind (to clinical and laboratory examiner) parallel-group randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Gingivitis, malocclusion treatment

Intervention

Subjects 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 type

Supplement

Phase

Drug names

Primary outcome measure

Gingival 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 measures

Measured 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 trial start date

01/02/2018

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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).

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

50 (allowing for dropouts)

Participant exclusion criteria

1. 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

Recruitment start date

01/04/2019

Recruitment end date

30/03/2020

Locations

Countries of recruitment

United Arab Emirates

Trial 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

Organisation

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

Sponsor details

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

Sponsor type

University/education

Website

https://www.mbruniversity.ac.ae

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Additional study documents will be available upon request. Presentations in congresses and publication in peer-reviewed articles.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes