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Efficacy of oral probiotics in improving oral hygiene for orthodontic patients

Efficacy of the oral probiotic Streptococcus salivarius in managing biofilm formation in patients wearing fixed orthodontic appliances: A double-blind randomized placebo-controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000341527
Enrollment
64
Registered
2015-04-15
Start date
2015-07-01
Completion date
2015-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is an increasing demand for orthodontic treatment due to its benefits in improving smiles, self-esteem and jaw function. However, braces make it more difficult to brush teeth effectively and therefore increase the accumulation of bacterial plaque (dental biofilm) in these hard-to-brush areas. Plaque can lead to problems such as tooth demineralization, bleeding gums and bad breath. These consequences significantly affect orthodontic treatment results and a patient’s quality of life. The prevalence of these biofilm-related problems, such as enamel demineralization, still remain as high as 72.9% in patients wearing braces. Many dental products are commercially available to prevent plaque buildup, with little effect. These include interdental brushes, specialized orthodontic toothbrushes, antimicrobial mouth rinses and toothpastes. The need for an effective measure of biofilm control is important and it is even greater in patients wearing braces. Probiotics are live ‘good’ bacteria that can inhibit ‘bad’ bacteria in biofilms. Regular consumption of oral probiotics has been reported as an effective way for managing plaque in preschool children, primary-school children, adolescents, adults and the elderly. However, the effect of oral probiotics on controlling biofilm in patients wearing braces has not been investigated to date. The probiotic Streptococcus salivarius, developed at the University of Otago, is the world’s first probiotic for the mouth. It has been shown to be effective and beneficial for the prevention and treatment of biofilm-related problems such as dental decay, gum inflammation and bad breath. We intend to investigate the effect of probiotic Streptococcus salivarius in managing the biofilm in patients wearing braces and see whether it can reduce dental biofilm accumulation, its unwanted side effects and offer patients a new beneficial oral micro-ecology.

Interventions

The probiotic lozenges that have been demonstrated efficacious in primary-school-aged children and university-aged adults will be used as the treatment intervention. These probiotic lozenges contain a probiotic strain, S. salivarius M18 (BLIS Technologies Ltd, Dunedin, New Zealand). The protocol will require the participants to suck two lozenges each day, one after brushing the teeth in the morning and one after teeth brushing at night. a) the dose administered: 3.6 billion S. salivarius CFUs/

The probiotic lozenges that have been demonstrated efficacious in primary-school-aged children and university-aged adults will be used as the treatment intervention. These probiotic lozenges contain a probiotic strain, S. salivarius M18 (BLIS Technologies Ltd, Dunedin, New Zealand). The protocol will require the participants to suck two lozenges each day, one after brushing the teeth in the morning and one after teeth brushing at night. a) the dose administered: 3.6 billion S. salivarius CFUs/lozenge; b) the duration/frequency of administration: daily for 4 weeks; c) the mode of administration: taken by mouth; d) strategy used to monitor adherence to the intervention: unused lozenge return.

Sponsors

Faculty of Dentistry, University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
10 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: age 10-30 years; at least 20 natural teeth (extraction and non extraction patients); wearing conventional stainless steel brackets (3M Unitek) in both arches; using a fluoride toothpaste not containing any supplementary antibacterial agents for daily oral hygiene. The patients will be willing to participate in the study and will be required to sign an informed consent form.

Exclusion criteria

Exclusion criteria: systemic disease (i.e. diabetes); periodontal diseases; antibiotic therapy; dental fluorosis; smoking; use of powered toothbrushes; lactose intolerant; allergic to dairy products.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026