On Probiotic, Dental Caries, and Orthodontic Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients

Conditions
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Dental Caries

Intervention / Treatment
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* Dietary Supplement: Active Probiotic
* Other: Placebo Probiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups matched in age and gender
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Probiotic<br>Probiotic contain active microorganism | Dietary Supplement: Active Probiotic<br>* Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659<br>|
| Placebo Comparator: Placebo Probiotic<br>Probiotic with no active microorganism | Other: Placebo Probiotic<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients. | 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Probiotics on Dental plaque | 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. | 3 weeks | 
| Effect of Probiotics on Saliva | 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? | 3 weeks |