Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients
Overview
- Phase
- Not Applicable
- Sponsor
- Göteborg University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
Overview
Brief Summary
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?
Detailed Description
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.
The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.
This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
3rd party will be involved in labeling the test and placebo samples
Eligibility Criteria
- Ages
- 14 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects undergoing bimaxillary fixed orthodontic treatment
- •Number of S. mutans counts (\>10.000 CFU/ml)
- •Permanent dentition
- •3-12 months into the treatment (study from Sweden by Andrea)
- •Medically healthy
- •Not taking any medication
- •Ability to understand the nature of the study and sign the consent form
Exclusion Criteria
- •Cleft lip and palate patients as well as handicapped and patients with mental impairments
- •Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
- •History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
- •Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
- •Habitual consumers of xylitol chewing gums
- •No active or untreated carious lesions and reported daily tooth brushing habit using fluoridated toothpaste
Outcomes
Primary Outcomes
Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
Time Frame: 3 weeks
Changes in the plaque pH (acidic or alkaline) is an important factor among others in the cares process, in which an acidic environment will help the bacteria to accumulate along the tooth surface and starting the caries lesions. So, considering the plaque pH as a clinical variable to show the probiotic effect is considered to be of great value.
Secondary Outcomes
- Effect of Probiotics on Saliva(3 weeks)
- Effect of Probiotics on Dental plaque(3 weeks)