Dental Caries
Conditions
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
Interventions
DIETARY_SUPPLEMENTActive Probiotic
Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659
OTHERPlacebo Probiotic
Placebo
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
3rd party will be involved in labeling the test and placebo samples
Intervention model description
Two groups matched in age and gender
Eligibility
Sex/Gender
ALL
Age
14 Years to 30 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients. | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of Probiotics on Dental plaque | 3 weeks | Plaque is an important aspect in caries detection, so the change in the plaque sample will show if the probiotic will help in the caries prevention during orthodontic treatment. |
| Effect of Probiotics on Saliva | 3 weeks | The saliva composition which includes cariogenic bacteria (caries initiating bacteria) such as Streptococcus mutans and lactobacilli, is an important factor in caries detection, so saliva sample will show if the probiotic is helpful in caries prevention? |
Countries
Sweden
Outcome results
None listed